Conte Presentation

•

0 j'aime•525 vues

K

Business Santé & Médecine

Innovator Pharmaceutical Companies at Risk for Products Manufactured by Generic Drug Companies in California: Defending Product Liability Claims in the Wake of Conte v. Wyeth Kelly Savage, Esq. Genese Dopson, Esq. FDAnews Webinar January 15, 2009

[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object]

Most Common Potential Claims: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object]

Today, you’ll learn more about California’s recent Conte v. Wyeth decision, and how it impacts defending product liability claims against your company here in California. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object]

[object Object]

[object Object]

[object Object]

[object Object]

[object Object]

Preemption Fundamentals – What is Preemption? ,[object Object],[object Object],[object Object]

Types of Preemption ,[object Object],[object Object],[object Object]

Why Should Preemption Matter to You? ,[object Object],[object Object],[object Object],[object Object],[object Object]

Recent example: Dennis Quaid and Baxter ,[object Object],[object Object],[object Object]

Baxter’s “Dear Doctor Letter” ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object]

[object Object]

NDA vs. ANDA Review Process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

What are the Basic Generic Drug Requirements? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Labeling ,[object Object],[object Object],[object Object]

[object Object]

Generic Drugs and Preemption ,[object Object],[object Object],[object Object]

[object Object]

Additional Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Contenu connexe

Tendances

NYLJ_Drug Patents in the Spotlight

NYLJ_Drug Patents in the Spotlight

NYLJ_Drug Patents in the Spotlight

Recent FDA Developments in Digital Health & Clinical Decision Support Software

Recent FDA Developments in Digital Health & Clinical Decision Support Software

Recent FDA Developments in Digital Health & Clinical Decision Support Software

Testosterone and Low-T Drugs Under Investigation AndroGel - Manufactured by AbbVie AndroDerm - Manufactured by Actavis Axiron - Manufactured by Eli Lilly and Company Bio-T-Gel - Manufactured by Teva Pharmaceuticals Fortesta - Manufactured by Endo Pharmaceuticals Striant - Manufactured by Columbia Laboratories Testim - Manufactured by Auxilium Pharmaceuticals Testopel - Manufactured by Auxilium Pharmaceuticals Delatestryl - Manufactured by Indevus Pharmaceuticals Depo-Testosterone - Manufactured by Pharmacia & Upjohn Company

Jpml1testosterone low testerone litigaiton brief in support of transfer

Jpml1testosterone low testerone litigaiton brief in support of transfer

Jpml1testosterone low testerone litigaiton brief in support of transfer

By paying $35 million, Walgreens settled allegations by pharmacist-whistleblower Bernard Lisitza that it unlawfully defrauded Medicaid by switching prescriptions for ranitidine, the generic form of the brand-name drug Zantac®, and fluoxetine, the generic form of Prozac®. The United States, Puerto Rico, 42 states, and the qui tam relator claimed that Walgreens improperly caused its pharmacies to switch Medicaid patients’ prescriptions from ranitidine tablets to ranitidine capsules, and from fluoxetine capsules to fluoxetine tablets. The alleged Medicaid fraud covered by the settlement lasted for more than four years, from July 16, 2001 through at least December 31, 2005. The complaint was brought in 2003 under the qui tam provisions of federal and state False Claims Acts, after whistleblower relator Bernard Lisitza uncovered the conduct and reported the problem to the government. The investigation and prosecution was led by the Attorneys General Offices in Florida, Illinois, Ohio, Texas and several other states, and by the United States Attorney’s Office in Chicago. Qui tam Relator Lisitza pursued the case with the assistance of his attorneys, Michael I. Behn and Linda Wyetzner, of Behn & Wyetzner, Chartered, in Chicago.

The Qui Tam Lawsuit Against Walgreens - the Federal Press Release

The Qui Tam Lawsuit Against Walgreens - the Federal Press Release

The Qui Tam Lawsuit Against Walgreens - the Federal Press Release

Behn Wyetzner, Chartered

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

steinuyvodepxvk

Use of testimonials and endorsements in prescription drug advertisements

Use of testimonials and endorsements in prescription drug advertisements

Use of testimonials and endorsements in prescription drug advertisements

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

wilsonqcclibsymd

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

unequaledkismet13

Why Compliance is a Tough Pill to Swallow – Nutraceuticals

Why Compliance is a Tough Pill to Swallow – Nutraceuticals

Why Compliance is a Tough Pill to Swallow – Nutraceuticals

Affiliate Summit

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

gruesomeknoll613

Press Release from the U.S. Dept. of Justice on Whistleblower Case Settlement...

Press Release from the U.S. Dept. of Justice on Whistleblower Case Settlement...

Press Release from the U.S. Dept. of Justice on Whistleblower Case Settlement...

Behn Wyetzner, Chartered

The Feds and Medical Cannabis: Signs Of Change or Business as Usual?

The Feds and Medical Cannabis: Signs Of Change or Business as Usual?

The Feds and Medical Cannabis: Signs Of Change or Business as Usual?

Latest Developments in and the Future of the Regulatory Landscape for Approv...

Latest Developments in and the Future of the Regulatory Landscape for Approv...

Latest Developments in and the Future of the Regulatory Landscape for Approv...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...

GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...

GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...

Health Canada Cracks Down on Illegal Growers, Again!

Health Canada Cracks Down on Illegal Growers, Again!

Health Canada Cracks Down on Illegal Growers, Again!

Generic Drug Labeling Proposed Rule: The Generic Drug Industry Perspective

Generic Drug Labeling Proposed Rule: The Generic Drug Industry Perspective

Generic Drug Labeling Proposed Rule: The Generic Drug Industry Perspective

Court documents filed in the U.S. District Court, Northern District of Illinois indicate that four testosterone treatment lawsuits were filed on February 4, 2014, on behalf of men who allegedly suffered serious heart problems due to the use of AndroGel. Among other things, the complaints raise questions about the marketing of prescription testosterone therapies, and accuse the manufacturers of the medications of promoting them as treatments for fatigue, low libido, and other problems associated with the aging process. The complaints further allege that these marketing tactics led to many patients being prescribed testosterone therapy, despite having normal levels of the hormone. (Case Nos: 1:14-cv-00776, 1:14-cv-00780, 1:14-cv-00777, and 1:14-cv-00772)

First LowT Complaint filed in Georgia Punitive Damages

First LowT Complaint filed in Georgia Punitive Damages

First LowT Complaint filed in Georgia Punitive Damages

“US Orphan Drug Market Outlook 2018” research report by KuicK Research comprehensive insight on following developments related to US orphan drug market: US Orphan Drug Market Overview Orphan Drug Designation Criteria Market Specific Reimbursement Policy & Regulatory Framework US Orphan Drug Pipeline by Phase, Indication & Originator Marketed Orphan drug List by Indication & Brand Name Key Issue to be Resolved Competitive Landscape

Us orphan drug market outlook 2018

Us orphan drug market outlook 2018

Us orphan drug market outlook 2018

Tendances (20)

NYLJ_Drug Patents in the Spotlight

NYLJ_Drug Patents in the Spotlight

NYLJ_Drug Patents in the Spotlight

Recent FDA Developments in Digital Health & Clinical Decision Support Software

Recent FDA Developments in Digital Health & Clinical Decision Support Software

Recent FDA Developments in Digital Health & Clinical Decision Support Software

Jpml1testosterone low testerone litigaiton brief in support of transfer

Jpml1testosterone low testerone litigaiton brief in support of transfer

Jpml1testosterone low testerone litigaiton brief in support of transfer

The Qui Tam Lawsuit Against Walgreens - the Federal Press Release

The Qui Tam Lawsuit Against Walgreens - the Federal Press Release

The Qui Tam Lawsuit Against Walgreens - the Federal Press Release

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

Use of testimonials and endorsements in prescription drug advertisements

Use of testimonials and endorsements in prescription drug advertisements

Use of testimonials and endorsements in prescription drug advertisements

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

Why Compliance is a Tough Pill to Swallow – Nutraceuticals

Why Compliance is a Tough Pill to Swallow – Nutraceuticals

Why Compliance is a Tough Pill to Swallow – Nutraceuticals

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

Press Release from the U.S. Dept. of Justice on Whistleblower Case Settlement...

Press Release from the U.S. Dept. of Justice on Whistleblower Case Settlement...

Press Release from the U.S. Dept. of Justice on Whistleblower Case Settlement...

The Feds and Medical Cannabis: Signs Of Change or Business as Usual?

The Feds and Medical Cannabis: Signs Of Change or Business as Usual?

The Feds and Medical Cannabis: Signs Of Change or Business as Usual?

Latest Developments in and the Future of the Regulatory Landscape for Approv...

Latest Developments in and the Future of the Regulatory Landscape for Approv...

Latest Developments in and the Future of the Regulatory Landscape for Approv...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GlaxoSmithKline's (GSK) $3 Billion Whistleblower Settlement Has Paid for One ...

GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...

GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...

GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...

Health Canada Cracks Down on Illegal Growers, Again!

Health Canada Cracks Down on Illegal Growers, Again!

Health Canada Cracks Down on Illegal Growers, Again!

Generic Drug Labeling Proposed Rule: The Generic Drug Industry Perspective

Generic Drug Labeling Proposed Rule: The Generic Drug Industry Perspective

Generic Drug Labeling Proposed Rule: The Generic Drug Industry Perspective

First LowT Complaint filed in Georgia Punitive Damages

First LowT Complaint filed in Georgia Punitive Damages

First LowT Complaint filed in Georgia Punitive Damages

Us orphan drug market outlook 2018

Us orphan drug market outlook 2018

Us orphan drug market outlook 2018

Similaire à Conte Presentation

Antitrust Aspects of Acquiring a Generic Drug Manufacturer

Antitrust Aspects of Acquiring a Generic Drug Manufacturer

Antitrust Aspects of Acquiring a Generic Drug Manufacturer

Anda

Malla Reddy College of Pharmacy

What you want to know about generic drugs

What you want to know about generic drugs

What you want to know about generic drugs

stewart granger

Naresh... anda ppt

Naresh... anda ppt

Naresh... anda ppt

Malla Reddy College of Pharmacy

Hatch- waxman act (The drug price competition and patent term restoration act...

Hatch- waxman act (The drug price competition and patent term restoration act...

Hatch- waxman act (The drug price competition and patent term restoration act...

Para i iv orange book

Para i iv orange book

Para i iv orange book

The Future of Off-Label Marketing Regulations in a Post Sorrell Era

The Future of Off-Label Marketing Regulations in a Post Sorrell Era

The Future of Off-Label Marketing Regulations in a Post Sorrell Era

Copy of The Future of Off-Label Marketing Regulations in the Post-Sorrell

Copy of The Future of Off-Label Marketing Regulations in the Post-Sorrell

Copy of The Future of Off-Label Marketing Regulations in the Post-Sorrell

Webinar sponsored by The Weinberg Group on Orphan Drugs, covering these topics: The Basics of the Orphan Drug Act Benefits of Orphan Drug status Exclusivity Protocol assistance, tax credits, and research grants When is an indication is “rare”? Orphan Drug Designation Requests – ensuring yours robust and persuasive Approval criteria for orphan products – how they compare to non-orphan products Challenges in the Orphan Drug Process

Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...

Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...

Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...

NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.

Market access conference NAPM

Market access conference NAPM

Market access conference NAPM

ANDA FDA APPLICATION

ANDA FDA APPLICATION

ANDA FDA APPLICATION

The life sciences industry is a key contributor to the Canadian and global economies. In the pursuit of competitive advantage, participants in the pharmaceutical, biotech, medical device and diagnostic, and health-careservices sectors have seen significant growth attributed to major leaps in technology and an unprecedented demand for health-related goods and services. This growth has paralleled the expansion and imposition of more stringent regulatory requirements, improvement of market access, aggressive patent acquisition and enforcement, strategic M&A activity, and increased product liability claims and other litigation. This report highlights insights and developments relating to a wide range of legal, business and consumer issues currently impacting the life sciences industry in Canada and abroad. These highlights were prepared by Blakes based on non-confidential information gathered in our practices, as well as through a review of publicly available information. Through a series of articles, we examine the implications of some of the recent legal developments impacting the sector, including the Supreme Court of Canada’s decision to uphold Ontario’s ban on private-label generic drugs, the enforcement of prohibitions on pharmacy-related loyalty points in B.C., the Competition Bureau’s ongoing consideration of competition among pharmaceutical companies, and recent trends in Canadian litigation. We also discuss issues relating to the navigation of transfer-pricing rules, protecting intellectual property in the development of combination products, and obtaining financing for new product development and business expansion efforts. Supplementing our discussion of these matters are snapshots of consumer-facing and market trends, including integrated patient care and direct-to-consumer sales.

Life Sciences Report

Life Sciences Report

Life Sciences Report

Blake, Cassels & Graydon LLP

MMHA 6135 WK 5 App

MMHA 6135 WK 5 App

MMHA 6135 WK 5 App

Off-Label Drug Promotion and the Use of Disclaimers* falseMcKenney, Dina. Texas Law Review92.1 (2013): 231-252. Abstract (summary) In July 2012, the Department of Justice (DOJ) announced a record health care fraud settlement: GlaxoSmithKline would pay $3 billion, in part to resolve allegations that the company engaged in off-label promotion of pharmaceutical drugs such as Paxil and Wellbutrin. According to both the DOJ and the Food and Drug Administration (FDA), promoting a drug for an off-label use is a violation of the Federal Food, Drug, and Cosmetic Act's misbranding provisions. In one of many allegations against GlaxoSmithKline, the government contended that the company unlawfully promoted Paxil for pediatric use, despite the fact that it was only approved for treating depression in individuals eighteen years of age and older. Part I examines the current regulatory scheme in place for off-label promotion and the possible benefits and consequences of allowing the promotion of off-label uses. Part II discusses how current case law regarding commercial speech threatens the government's off-label promotion prosecution scheme. In July 2012, the Department of Justice (DOJ) announced a record health care fraud settlement: GlaxoSmithKline would pay $3 billion, in part to resolve allegations that the company engaged in off-label promotion of pharmaceutical drugs such as Paxil and Wellbutrin. According to both the DOJ and the Food and Drug Administration (FDA), promoting a drug for an off-label use is a violation of the Federal Food, Drug, and Cosmetic Act's misbranding provisions. In one of many allegations against GlaxoSmithKline, the government contended that the company unlawfully promoted Paxil for pediatric use, despite the fact that it was only approved for treating depression in individuals eighteen years of age and older. Part I examines the current regulatory scheme in place for off-label promotion and the possible benefits and consequences of allowing the promotion of off-label uses. Part II discusses how current case law regarding commercial speech threatens the government's off-label promotion prosecution scheme. You have requested "on-the-fly" machine translation of selected content from our databases. This functionality is provided solely for your convenience and is in no way intended to replace human translation. Show full disclaimer Neither ProQuest nor its licensors make any representations or warranties with respect to the translations. The translations are automatically generated "AS IS" and "AS AVAILABLE" and are not retained in our systems. PROQUEST AND ITS LICENSORS SPECIFICALLY DISCLAIM ANY AND ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES FOR AVAILABILITY, ACCURACY, TIMELINESS, COMPLETENESS, NON-INFRINGMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Your use of the translations is subject to all use restrictions contained in your Electronic Products License Agreement and by .

Off-Label Drug Promotion and the Use of DisclaimersfalseMcKenney,.docx

Off-Label Drug Promotion and the Use of DisclaimersfalseMcKenney,.docx

Off-Label Drug Promotion and the Use of DisclaimersfalseMcKenney,.docx

hopeaustin33688

Comparative study of Patent laws In United States, Canada and Patent infringe...

Comparative study of Patent laws In United States, Canada and Patent infringe...

Comparative study of Patent laws In United States, Canada and Patent infringe...

SriramNagarajan17

Dr. Ravi Dhar reviews "IP Barriers in Generic Vaccines in 2014"

Dr. Ravi Dhar reviews "IP Barriers in Generic Vaccines in 2014"

Dr. Ravi Dhar reviews "IP Barriers in Generic Vaccines in 2014"

IN THIS SUMMARY The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency. SUBSCRIBE TODAY http://www.bizsum.com/summaries/inside-fda

Inside the FDA

Business Book Summaries

Generic Drugs and Biosimilars

Generic Drugs and Biosimilars

Generic Drugs and Biosimilars

Drug Use, Regulation, and the Law Chapter 3 Guidelines for Controlling Drug Development and Marketing Society has the right to protect itself from the damaging impact of drug use. Society has the right to demand safe and effective drugs. Strategies for Preventing Drug Abuse Supply reduction Using drug laws to control the manufacturing and distribution of classified drugs Inoculation Aims to protect drug users by teaching them responsibility and explaining the effects of drugs on bodily and mental functioning Demand reduction strategy Aims to reduce the actual demand for drugs 3 Patent Medicines The term patent medicines signified that the ingredients were secret, not patented. The patent medicines of the late 1800s and early 1900s demonstrated the problems of insufficient regulation of the drug industry. Issues Leading to Legislation Fraud in patent medicines that were sold directly to the public False therapeutic claims Habit-forming drug content 5 Image source: Library of Congress Prints and Photographs Division (Images Ch03_05PatMedKentucky, Ch03_03PatMedJayne) Issues Leading to Legislation Cocaine Present in many patent medicines Viewed as a cause of increasing crime 6 Image source: National Library of Medicine, National Institutes of Health (See image bank for Chapter 6; Image Ch06_06CocaineDrops) Reformism Current laws trace back to two pieces of legislation from the early 1900s Racist fears about deviant behavior, including drug misuse, played a role in the development of drug regulation Laws were developed to regulate undesirable behaviors 7 Image source: Library of Congress Prints and Photographs Division (Image Ch03_08OpiumPoster1) Issues Leading to Legislation Opium and the Chinese U.S. was involved in international drug trade Opium smoking brought to U.S. by Chinese workers (myth) Laws passed against the importation, manufacture, and use of opium 8 Image source: Library of Congress Prints and Photographs Division (Image Ch03_07OpiumDen) Issues Leading to Legislation In the early 1900s, Collier’s magazine ran a series of articles attacking patent medicines. Drug manufacturers have a history of selling ineffective, addictive and even harmful products to the public. 9 Image source: Library of Congress Prints and Photographs Division (Image Ch03_06ColliersMagazine) 1906 Pure Food and Drugs Act Federal government law to protect the public (Dept. of Agriculture) Required accurate labeling and listing of ingredients US Government intervenes in commerce of adulterated or misbranded drugs and food Misbranding only refers to the label, not advertising 10 The 1906 Pure Food and Drug Act Required manufacturers to include on labels the amounts of alcohol, morphine, opium, cocaine, heroin, or marijuana extract in each product Did not prohibit distribution of dangerous preparations The Sherley Amendment in 1912 Accuracy of manufacturers’ therapeutic claims was not controlled by the P ...

Drug Use, Regulation, and the LawChapter 3Guid.docx

Drug Use, Regulation, and the LawChapter 3Guid.docx

Drug Use, Regulation, and the LawChapter 3Guid.docx

Generic drugs and their importance

Generic drugs and their importance

Generic drugs and their importance

Similaire à Conte Presentation (20)

Antitrust Aspects of Acquiring a Generic Drug Manufacturer

Antitrust Aspects of Acquiring a Generic Drug Manufacturer

Antitrust Aspects of Acquiring a Generic Drug Manufacturer

Anda

What you want to know about generic drugs

What you want to know about generic drugs

What you want to know about generic drugs

Naresh... anda ppt

Naresh... anda ppt

Naresh... anda ppt

Hatch- waxman act (The drug price competition and patent term restoration act...

Hatch- waxman act (The drug price competition and patent term restoration act...

Hatch- waxman act (The drug price competition and patent term restoration act...

Para i iv orange book

Para i iv orange book

Para i iv orange book

The Future of Off-Label Marketing Regulations in a Post Sorrell Era

The Future of Off-Label Marketing Regulations in a Post Sorrell Era

The Future of Off-Label Marketing Regulations in a Post Sorrell Era

Copy of The Future of Off-Label Marketing Regulations in the Post-Sorrell

Copy of The Future of Off-Label Marketing Regulations in the Post-Sorrell

Copy of The Future of Off-Label Marketing Regulations in the Post-Sorrell

Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...

Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...

Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...

Market access conference NAPM

Market access conference NAPM

Market access conference NAPM

ANDA FDA APPLICATION

ANDA FDA APPLICATION

ANDA FDA APPLICATION

Life Sciences Report

Life Sciences Report

Life Sciences Report

MMHA 6135 WK 5 App

MMHA 6135 WK 5 App

MMHA 6135 WK 5 App

Off-Label Drug Promotion and the Use of DisclaimersfalseMcKenney,.docx

Off-Label Drug Promotion and the Use of DisclaimersfalseMcKenney,.docx

Off-Label Drug Promotion and the Use of DisclaimersfalseMcKenney,.docx

Comparative study of Patent laws In United States, Canada and Patent infringe...

Comparative study of Patent laws In United States, Canada and Patent infringe...

Comparative study of Patent laws In United States, Canada and Patent infringe...

Dr. Ravi Dhar reviews "IP Barriers in Generic Vaccines in 2014"

Dr. Ravi Dhar reviews "IP Barriers in Generic Vaccines in 2014"

Dr. Ravi Dhar reviews "IP Barriers in Generic Vaccines in 2014"

Inside the FDA

Generic Drugs and Biosimilars

Generic Drugs and Biosimilars

Generic Drugs and Biosimilars

Drug Use, Regulation, and the LawChapter 3Guid.docx

Drug Use, Regulation, and the LawChapter 3Guid.docx

Drug Use, Regulation, and the LawChapter 3Guid.docx

Generic drugs and their importance

Generic drugs and their importance

Generic drugs and their importance

Dernier

Insurance IoT is a social good! Because: 🔵 Expected losses can be reduced structured programs with both real-time mitigation actions to solve a specific situation, and behavioral change mechanisms to promote safer behaviors (both in personal and commercial lines) 🔵 Rate can be matched to risks better: - Smaller and more accurate pricing clusters allow a large part of profiles to receive a lower rate - Even with the ability to price the individual probability of loss (cluster of one) the insurance foundation isn’t canceled (The risk of each policy will contribute to the expected losses of the portfolio; The premiums paid by many lucky policyholders will be used to pay the claims of the few unlucky policyholders who had an accident in a period of coverage) 🔵 IoT data can be used to increase the effectiveness and efficiency of the claim process, so improving the combined ratio ceteris paribus ⏩ Large part of the policyholders will pay less (and portfolios currently difficult to insure will become more insurable) Insurance IoT (and telematics) is not about providing a discount Insurance IoT (and telematics) is about creating economic value using the data and sharing part of this value with policyholders (and agents & brokers) An integrated holistic adoption of the IoT paradigm is a game changer for your insurance business and a social good: ◾ it allows to improve the availability and affordability of insurance coverages ◾while allowing the sector to write a profitable business Below you can enjoy a selection of best practices in both personal and commercial lines - written with some of the IoT Insurance Observatory members - that have already started to obtain results from their IoT business transformation journeys

Insurers' journeys to build a mastery in the IoT usage

Insurers' journeys to build a mastery in the IoT usage

Insurers' journeys to build a mastery in the IoT usage

Call Girls In Goa 9971646499 Panjim Direct Escorts Girls I Love New Experience And Enjoying The Plesures Of Sex And Company Im Verry Sociable , Funny And Entertainment Make You Forget About All Your Problems For An Or Hours More.. My Body And My Abilites Will Make You Verry Horny And Empty Your Balls And Very Accommodating . I Guarantee You An excellent treatment And The Best Night Of Pleasure In Bed Im Quite Provocative And Spontanous The Hotest LoverYou Will Meet I Want Show You A Women Like Me Realy Good Care Of Men Like You I will Leave You At Easy And Super Satisfied Let"s MAke Every Minutes Our erotic Sesssion Of Last I Will Amazing You When You ill Be Alone I Know Many Ways To make You Happy You Can Contact Me 9971646499 Or Whatsapp

Call Girls In Panjim North Goa 9971646499 Genuine Service

Call Girls In Panjim North Goa 9971646499 Genuine Service

Call Girls In Panjim North Goa 9971646499 Genuine Service

CALL NOW 98787-99926 CHANDIGARH BEST Call Girls in CHANDIGARH Escort Service provide Cute Nice sweet and Sexy Models in beautiful CHANDIGARH city cash in hand to hand call girl in CHANDIGARH and CHANDIGARH escorts. HOT & SEXY MODELS // COLLEGE GIRLS IN CHANDIGARH AVAILABLE FOR COMPLETE ENJOYMENT WITH HIGH PROFILE INDIAN MODEL AVAILABLE HOTEL & HOME ★ SAFE AND SECURE HIGH CLASS SERVICE AFFORDABLE RATE ★ 100% SATISFACTION,UNLIMITED ENJOYMENT. ★ All Meetings are confidential and no information is provided to any one at any cost. ★ EXCLUSIVE Profiles Are Safe and Consensual with Most Limits Respected ★ Service Available In: - HOME & 24x7 :: 3 * 5 *7 *Star Hotel Service .In Call & Out call Services : ★ A-Level (5 star escort) ★ Strip-tease ★ BBBJ (Bareback Blowjob)Receive advanced sexual techniques in different mode make their life more pleasurable. ★ Spending time in hotel rooms ★ BJ (Blowjob Without a Condom) ★ Completion (Oral to completion) ★ Covered (Covered blowjob Without a Condom)👉Chandigarh Call Girls 👉9878799926👉Just Call👉Chandigarh Call Girl In Chandigarh No Advance Only Cash On Delivery

👉Chandigarh Call Girls 👉9878799926👉Just Call👉Chandigarh Call Girl In Chandiga...

👉Chandigarh Call Girls 👉9878799926👉Just Call👉Chandigarh Call Girl In Chandiga...

👉Chandigarh Call Girls 👉9878799926👉Just Call👉Chandigarh Call Girl In Chandiga...

rajveerescorts2022

Are you looking for some sexual fun and erotic girl in the vibrant city of Lucknow? Look no further than our top-notch call girl services in Lucknow! Whether you prefer in-call or out-call services, we just need to call or WhatsApp us at 7388211116 In-call and Out-call services for Call girls in Lucknow Looking for privacy? Our in-call services provide a discreet and comfortable setting for your rendezvous with our lovely call girls in Lucknow. Best Price with hotel services When looking for the best-priced call girl in Lucknow, our services at Lucknow Call Girl Service stand out with our exceptional BDSM, GFE, Oral Experience, etc. We provide top-notch experiences that cater to your needs and desires, ensuring a memorable encounter every time. Call or WhatsApp us for more details - 7388211116

Call Girls in Gomti Nagar - 7388211116 - With room Service

Call Girls in Gomti Nagar - 7388211116 - With room Service

Call Girls in Gomti Nagar - 7388211116 - With room Service

discovermytutordmt

Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...

Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...

Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...

Organisational success today depends on effective communication and collaboration with individuals from cultures with varying beliefs and practices. Indeed, with the workforce increasingly comprised of people of varying cultural backgrounds, leaders must now prioritise the significance of cultural competence in the workplace. Ensuring cultural competence at every level of your organisation cannot be understated. While cultural disparities can manifest in different ways, as a leader, you must build deep and nuanced cultural competence skills and education to accurately spot, address and alleviate the various scenarios that can arise. Failing to recognise the importance of cultural competence or not acting to improve it can lead to cultural negligence. There are a few things to consider to ensure your organisation is on the right track. In this deck, you'll understand the importance of building cultural competence in the workplace. You'll also learn • The three (3) dimensions of Cultural Competence in the workplace • Key strategies to build a culturally competent workforce • Major benefits you stand to gain by having a culturally competent team.

Cracking the Cultural Competence Code.pptx

Cracking the Cultural Competence Code.pptx

Cracking the Cultural Competence Code.pptx

Workforce Group

It will be International Nurses' Day on 12 May

It will be International Nurses' Day on 12 May

It will be International Nurses' Day on 12 May

0183760ssssssssssssssssssssssssssss00101011 (27).pdf

0183760ssssssssssssssssssssssssssss00101011 (27).pdf

0183760ssssssssssssssssssssssssssss00101011 (27).pdf

Dive into the world of sales excellence with 'A Day in the Life of a Salesman/Woman.' This presentation offers insights into the daily routines and strategies of dedicated sales professionals, covering everything from strategic planning to closing deals. Explore key insights and practical tips for navigating the modern marketplace while celebrating the passion and purpose of those who drive the business forward.

A DAY IN THE LIFE OF A SALESMAN / WOMAN

A DAY IN THE LIFE OF A SALESMAN / WOMAN

A DAY IN THE LIFE OF A SALESMAN / WOMAN

IlamathiKannappan

VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒

VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒

VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒

John Halpern sued for sexual assault.pdf

John Halpern sued for sexual assault.pdf

John Halpern sued for sexual assault.pdf

Value Proposition canvas- Customer needs and pains

Value Proposition canvas- Customer needs and pains

Value Proposition canvas- Customer needs and pains

Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...

Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...

Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...

Lviv Startup Club

VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS Live Booking Contact Details :- WhatsApp Chat :- [+91-9999965857 ] The Best Call Girls Delhi At Your Service Russian Call Girls Delhi Doing anything intimate with can be a wonderful way to unwind from life's stresses, while having some fun. These girls specialize in providing sexual pleasure that will satisfy your fetishes; from tease and seduce their clients to keeping it all confidential - these services are also available both install and outcall, making them great additions for parties or business events alike. Their expert sex skills include deep penetration, oral sex, cum eating and cum eating - always respecting your wishes as part of the experience (07-May-2024(PSS)

VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...

VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...

VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...

Call Girls In Delhi Whatsup 9873940964 Enjoy Unlimited Pleasure

Famous Olympic Siblings from the 21st Century

Famous Olympic Siblings from the 21st Century

Famous Olympic Siblings from the 21st Century

MONA 98765-12871 CALL GIRLS IN LUDHIANA LUDHIANA CALL GIRL

MONA 98765-12871 CALL GIRLS IN LUDHIANA LUDHIANA CALL GIRL

MONA 98765-12871 CALL GIRLS IN LUDHIANA LUDHIANA CALL GIRL

Saudi Arabia [ Abortion pills) Jeddah/riaydh/dammam/++918133066128☎️] cytotec tablets uses abortion pills 💊💊 How effective is the abortion pill? 💊💊 +918133066128) "Abortion pills in Jeddah" how to get cytotec tablets in Riyadh " Abortion pills in dammam*💊💊 The abortion pill is very effective. If you’re taking mifepristone and misoprostol, it depends on how far along the pregnancy is, and how many doses of medicine you take:💊💊 +918133066128) how to buy cytotec pills At 8 weeks pregnant or less, it works about 94-98% of the time. +918133066128[ 💊💊💊 At 8-9 weeks pregnant, it works about 94-96% of the time. +918133066128) At 9-10 weeks pregnant, it works about 91-93% of the time. +918133066128)💊💊 If you take an extra dose of misoprostol, it works about 99% of the time. At 10-11 weeks pregnant, it works about 87% of the time. +918133066128) If you take an extra dose of misoprostol, it works about 98% of the time. In general, taking both mifepristone and+918133066128 misoprostol works a bit better than taking misoprostol only. +918133066128 Taking misoprostol alone works to end the+918133066128 pregnancy about 85-95% of the time — depending on how far along the+918133066128 pregnancy is and how you take the medicine. +918133066128 The abortion pill usually works, but if it doesn’t, you can take more medicine or have an in-clinic abortion. +918133066128 When can I take the abortion pill?+918133066128 In general, you can have a medication abortion up to 77 days (11 weeks)+918133066128 after the first day of your last period. If it’s been 78 days or more since the first day of your last+918133066128 period, you can have an in-clinic abortion to end your pregnancy.+918133066128 Why do people choose the abortion pill? Which kind of abortion you choose all depends on your personal+918133066128 preference and situation. With+918133066128 medication+918133066128 abortion, some people like that you don’t need to have a procedure in a doctor’s office. You can have your medication abortion on your own+918133066128 schedule, at home or in another comfortable place that you choose.+918133066128 You get to decide who you want to be with during your abortion, or you can go it alone. Because+918133066128 medication abortion is similar to a miscarriage, many people feel like it’s more “natural” and less invasive. And some+918133066128 people may not have an in-clinic abortion provider close by, so abortion pills are more available to+918133066128 them. +918133066128 Your doctor, nurse, or health center staff can help you decide which kind of abortion is best for you. +918133066128 More questions from patients: Saudi Arabia+918133066128 CYTOTEC Misoprostol Tablets. Misoprostol is a medication that can prevent stomach ulcers if you also take NSAID medications. It reduces the amount of acid in your stomach, which protects your stomach lining. The brand name of this medication is Cytotec®.+918133066128) Unwanted Kit

Mifty kit IN Salmiya (+918133066128) Abortion pills IN Salmiyah Cytotec pills

Mifty kit IN Salmiya (+918133066128) Abortion pills IN Salmiyah Cytotec pills

Mifty kit IN Salmiya (+918133066128) Abortion pills IN Salmiyah Cytotec pills

Abortion pills in Kuwait Cytotec pills in Kuwait

https://www.productmanagementtoday.com/frs/26795801/the-path-to-product-excellence--avoiding-common-pitfalls-and-enhancing-communication In the fast-paced world of digital innovation, success is often accompanied by a multitude of challenges - like the pitfalls lurking at every turn, threatening to derail the most promising projects. But fret not, this webinar is your key to effective product development! Join us for an enlightening session to empower you to lead your team to greater heights. Through compelling storytelling and actionable insights, learn to overcome challenges like misaligned objectives, communication breakdowns, and resistance to change. Takeaways: • Uncover and navigate through common pitfalls that are plaguing product teams today. • Explore proven solutions, laying the groundwork for triumphant product launches. • Gain inspiration from real-world success examples from top digital companies, offering invaluable insights into their winning strategies. • Discover how the symbiotic relationship between product managers, UX/UI designers, and developers can transform pitfalls into opportunities, propelling your product outcomes to unprecedented heights.

The Path to Product Excellence: Avoiding Common Pitfalls and Enhancing Commun...

The Path to Product Excellence: Avoiding Common Pitfalls and Enhancing Commun...

The Path to Product Excellence: Avoiding Common Pitfalls and Enhancing Commun...

B.COM Unit – 4 ( CORPORATE SOCIAL RESPONSIBILITY ( CSR ).pptx

B.COM Unit – 4 ( CORPORATE SOCIAL RESPONSIBILITY ( CSR ).pptx

B.COM Unit – 4 ( CORPORATE SOCIAL RESPONSIBILITY ( CSR ).pptx

priyanshujha201

KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...

KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...

KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...

Any kyc Account

Dernier (20)

Insurers' journeys to build a mastery in the IoT usage

Insurers' journeys to build a mastery in the IoT usage

Insurers' journeys to build a mastery in the IoT usage

Call Girls In Panjim North Goa 9971646499 Genuine Service

Call Girls In Panjim North Goa 9971646499 Genuine Service

Call Girls In Panjim North Goa 9971646499 Genuine Service

👉Chandigarh Call Girls 👉9878799926👉Just Call👉Chandigarh Call Girl In Chandiga...

👉Chandigarh Call Girls 👉9878799926👉Just Call👉Chandigarh Call Girl In Chandiga...

👉Chandigarh Call Girls 👉9878799926👉Just Call👉Chandigarh Call Girl In Chandiga...

Call Girls in Gomti Nagar - 7388211116 - With room Service

Call Girls in Gomti Nagar - 7388211116 - With room Service

Call Girls in Gomti Nagar - 7388211116 - With room Service

Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...

Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...

Enhancing and Restoring Safety & Quality Cultures - Dave Litwiller - May 2024...

Cracking the Cultural Competence Code.pptx

Cracking the Cultural Competence Code.pptx

Cracking the Cultural Competence Code.pptx

It will be International Nurses' Day on 12 May

It will be International Nurses' Day on 12 May

It will be International Nurses' Day on 12 May

0183760ssssssssssssssssssssssssssss00101011 (27).pdf

0183760ssssssssssssssssssssssssssss00101011 (27).pdf

0183760ssssssssssssssssssssssssssss00101011 (27).pdf

A DAY IN THE LIFE OF A SALESMAN / WOMAN

A DAY IN THE LIFE OF A SALESMAN / WOMAN

A DAY IN THE LIFE OF A SALESMAN / WOMAN

VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒

VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒

VIP Call Girls In Saharaganj ( Lucknow ) 🔝 8923113531 🔝 Cash Payment (COD) 👒

John Halpern sued for sexual assault.pdf

John Halpern sued for sexual assault.pdf

John Halpern sued for sexual assault.pdf

Value Proposition canvas- Customer needs and pains

Value Proposition canvas- Customer needs and pains

Value Proposition canvas- Customer needs and pains

Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...

Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...

Yaroslav Rozhankivskyy: Три складові і три передумови максимальної продуктивн...

VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...

VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...

VVVIP Call Girls In Greater Kailash ➡️ Delhi ➡️ 9999965857 🚀 No Advance 24HRS...

Famous Olympic Siblings from the 21st Century

Famous Olympic Siblings from the 21st Century

Famous Olympic Siblings from the 21st Century

MONA 98765-12871 CALL GIRLS IN LUDHIANA LUDHIANA CALL GIRL

MONA 98765-12871 CALL GIRLS IN LUDHIANA LUDHIANA CALL GIRL

MONA 98765-12871 CALL GIRLS IN LUDHIANA LUDHIANA CALL GIRL

Mifty kit IN Salmiya (+918133066128) Abortion pills IN Salmiyah Cytotec pills

Mifty kit IN Salmiya (+918133066128) Abortion pills IN Salmiyah Cytotec pills

Mifty kit IN Salmiya (+918133066128) Abortion pills IN Salmiyah Cytotec pills

The Path to Product Excellence: Avoiding Common Pitfalls and Enhancing Commun...

The Path to Product Excellence: Avoiding Common Pitfalls and Enhancing Commun...

The Path to Product Excellence: Avoiding Common Pitfalls and Enhancing Commun...

B.COM Unit – 4 ( CORPORATE SOCIAL RESPONSIBILITY ( CSR ).pptx

B.COM Unit – 4 ( CORPORATE SOCIAL RESPONSIBILITY ( CSR ).pptx

B.COM Unit – 4 ( CORPORATE SOCIAL RESPONSIBILITY ( CSR ).pptx

KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...

KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...

KYC-Verified Accounts: Helping Companies Handle Challenging Regulatory Enviro...

Conte Presentation

1. Innovator Pharmaceutical Companies at Risk for Products Manufactured by Generic Drug Companies in California: Defending Product Liability Claims in the Wake of Conte v. Wyeth Kelly Savage, Esq. Genese Dopson, Esq. FDAnews Webinar January 15, 2009

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

27.

28.