Cder

INTRODUCTION
ABOUT CDER
DRUG INFORMATION
REGULATORY GUIDANCE
CDER CALENDER
SPECIFIC AUDIENCES
CDER ARCHIVES
POSSIBLE QUESTIONS
REFERENCES

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION (FDA)

Center for Center for Food
Center for Drug Biologics Safety & Applied National Center
Evaluation & Evaluation & Nutrition for Toxicological
Research Research (CFSAN) Research
(CDER) (CBER)
Center for Center for
Devices & Veterinary
Radiological Medicine
Health (CVM)
(CDRH)
Office of the Office of
Commissioner Regulatory
Affairs

Center for Drug Evaluation and Research

1. ABOUT CDER
1.1 Who We Are:

1.1.1 CDER Personnel Directories
1.1.2 FDA Fact Sheet about CDER:
Improving Public Health: Promoting Safe
and Effective Drug Use.
1.1.3 FDA Fact Sheet about Drugs
1.1.4 Organization charts
1.1.5 CDER Office and Subject Home Page


1.2 What We Do:

1.2.1


1.2 What We Do:
1.2.2 CDER Drug Product Applications

1.2.3 CDER Small Business Assistance
Program


1.2 What We Do:
1.2.4 CDER Handbook

1.2.4.1 New Drug Development and Review
1.2.4.2 Generic Drug Review
1.2.4.3 Over-the-Counter Drug Review
1.2.4.4 Post Drug Approval Activities.
1.2.4.5 Communicating with CDER
1.2.4.6 Other activities


1.2.4.1 The New Drug Development Process:
Steps from Test Tube to New Drug Application Review

1.2.4.2 Generic Drug Review Process

1.2.4.3 Over-the-Counter Drug
Review Process
Over-the-Counter Drug Products

Introduction


What is the need for over the counter
drug review process

There are more than 100,000 OTC drug products marketed,
encompassing about 800 significant active ingredients.
Most OTC drug products have been marketed for many
years, prior to the laws that require proof of safety and
effectiveness before marketing. For this reason, FDA has
been evaluating the ingredients and labeling of these
products as part of "The OTC Drug Review Program."


of "The OTC Drug Review
Program."
The goal of this program is to establish OTC drug monographs
for each class of products. OTC drug monographs are a kind of
"recipe book" covering acceptable ingredients, doses,
formulations, and labeling. Monographs will continually be
updated adding additional ingredients and labeling as needed.


1.2.4.3 OTC Drug Review Process

1.2.4.4 Post Drug Approval Activities
1.2.4.4 a) Post-Marketing Surveillance
1.2.4.4 b) Prescription Drug Advertising and
Promotional Labeling
1.2.4.4 c) Pharmaceutical Industry Surveillance
1.2.4.4 d) Medication Errors
1.2.4.4 e) Drug Shortages
1.2.4.4 f) Therapeutic Inequivalence Reporting


Post-Marketing Surveillance (PMS)

PMS Information Sources Chart
MEDWatch
Spontaneous Reporting System
Pharmacoepidemiology
Contracts/Co-operative Agreements


PMS Information Source Chart


MEDWatch has four goals:
• Make it easier for healthcare providers to report
serious events.
• Make it clearer to healthcare providers what types
of adverse events FDA is interested in receiving.
• More widely disseminate information on the
FDA's actions that have resulted from adverse
event and product problem reporting.
• Increase healthcare providers' understanding and
awareness of drug and device-induced disease.


Spontaneous Reporting System (SRS)

CDER's Division of Pharmacovigilance and Epidemiology
maintains a Spontaneous Reporting System (SRS) which
contains the adverse drug reaction reports from hospitals,
health care providers and lay persons that are sent either
directly to the Agency (via MEDWatch) or first to the
drug manufacturer, and then, by regulation, to the Agency
by the manufacturer.
In the near future, SRS will be replaced by an expanded
system called the Adverse Events Reporting System
(AERS), currently under development.


1.2.4.4 b) Prescription Drug Advertising
and Promotional Labeling

Part of CDER's mission is to assure that prescription drug
information provided by drug firms is truthful, balanced, and
accurately communicated. This is accomplished through a
comprehensive surveillance, enforcement, and education
program, and by fostering better communications of labeling
and promotional information to both health professionals and
consumers.
This work is accomplished primarily through CDER's
Division of Drug Marketing, Advertising and
Communications (DDMAC).


1.2.4.4 c) Pharmaceutical Industry Surveillance

• Government oversight of the pharmaceutical industry is usually
classified into preapproval and post-approval categories.
• After the drug is approved and marketed, the FDA uses different
mechanisms for assuring that firms adhere to the terms and conditions
of approval described in the application and that the drug is
manufactured in a consistent and controlled manner.
• This is done by periodic unannounced inspections of drug production
and control facilities by FDA’s field investigators and analysts. These
professionals are organized under FDA’s Office of Regulatory Affairs
(ORA), which has twenty-one district offices and many more resident
posts throughout the country.


1.2.4.4 d) Medication Errors

prescribing,
repackaging,
dispensing,
administering, or
monitoring.


1.2.4.4 e) Drug Shortages

It is FDA's policy to attempt to prevent or alleviate shortages of
medically necessary products.

Reporting Drug Shortages

External reports on drug shortages are received in CDER through a variety of
means. One such means is the Drug Shortage System which is maintained by
the Center's Drug Quality Reporting System (DQRS).
DQRS is the preferred entry point for consumer reports of drug shortages.
Other sources of drug shortage information include FDA's Office of Health
Affairs, which is a focal point for drug shortage reports from health
professionals.


1.2.4.4 f) Therapeutic Inequivalence
Reporting

In the past 10 years, FDA's Center for Drug Evaluation and Research
has received more and more reports of drug products that fail to work in
patients because the product simply has no effect or is toxic. These
problems are usually attributed to switching brands of drugs.
As a result, on Sept. 14, 1988, FDA created in CDER the Therapeutic
Inequivalence Action Coordinating Committee (TIACC) to identify and
evaluate reports of therapeutic failures and toxicity that could indicate
that one product is not equivalent to another similar product.


1.2.4.5 Communicating with CDER
1.2.4.5 a) Consumer/Industry Inquiries -Division of
Communications Management (DCM)
1.2.4.5 b) Regulatory Correspondence
1.2.4.5 c) CDER Ombudsman
1.2.4.5 d) Videoconferencing


1.2.4.6 Other Activities

1.2.4.6 a) Orphan Drugs
1.2.4.6 b) Drug Registration and Listing System
1.2.4.6 c) Environmental Assessments
1.2.4.6 d) Women's Health Issues
1.2.4.6 e) CDER Pediatric Initiatives
1.2.4.6 f) "International Conference on
Harmonization"


1.2 What We Do:
 Center for Drug Evaluation and Research Fact Book 1997 -
This publication provides an overview of the diversity of activities and responsibilities within the
Center.
 FDA Consumer - Articles with Information About CDER and Our Drug Review Process
 FDA Consumer Magazine - An archive of FDA Consumer Magazine from 1989-Present.
 FDA News - Latest Information from the U.S. Food and Drug Administration - Press releases and
additional information not found on this CDER home page.
 From Test Tube to Patient: Improving Health Through Human Drugs (2/2006)
 Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective
Collaborations. [HTML] or [PDF] (3/12/2003)
 Human Drug Advisory Committees. Links to meeting transcripts and related information.
 Managing the Risks from Medical Product Use: Creating a Risk Management Framework (Posted
5/10/1999). Executive Summary . Full Report (164 pages) .
 Manual of Policies and Procedures (MaPPs) . CDER's official policies and procedures manual.
 Questions About CDER (4/17/2000). Answers to some commonly asked questions about
CDER.
 Reviewer Diagram Project (6/23/1999). Several approaches to reviewing drug applications
 Small Business Guide to FDA. About FDA's organization, procedures, policies, and regulations.


1.3 What We have Accomplished:
1.3.1 News Along the Pike
1.3.2 CDER 2004 Report to the Nation:
Improving Public Health Through Human
Drugs.
1.3.3 FDA's Drug Review and Approval Times
1.3.4 New Drug Approval Reports Status reports
of drug approvals by calendar year.
1.3.5 Prescription Drug User Fee Act (PDUFA) Reports to Congress
1.3.6 Office of Drug Safety Annual Report 2001


1.4 Regulatory Authority
Compilation of Laws and Related Statutes Enforced b

Federal Food, Drug, and Cosmetic Act


1.5Feedback from Stakeholders
Conversation with Stakeholders Report-April 1999


1.6 Training

New Drug Development in the United States


1.7 Employment Opportunities at CDER


1.8 How to Contact Us:

Drug Information Questions
Ombudsman
Policy Questions
Web Site Feedback


2. DRUG INFORMATION
2.1 New Prescription Drug Approvals

• Drugs@FDA
• New and Generic Drug Approvals - This is an alphabetical listing of all
prescription and over-the-counter drugs approved during 1998 through
2003. It is updated on a daily basis and contains links to labels, approval
letters, and reviews.
• Index to Drug-Specific Information -Provides links to Consumer, Patient,
and Healthcare Professional Sheets, and more.
• FDA Drug Approvals List- This is a reverse chronological listing of all
drugs approved from September 1996 to August 12, 2002.
• New Drugs Approved for Cancer Indications- This is a current listing of
new cancer drugs. It is prepared by FDA's Office of Special Health Issues .


2.2 Prescription Drug Information
Approved Drug Products with Therapeutic Equivalence Evaluations/Orange Book
. The Orange Book lists all FDA approved prescription drugs, including new
and generic drugs. The Orange Book Page includes a searchable Orange Book,
as well as a text version, supplements, and downloadable data files. It is
updated on a monthly basis.
Biological Therapeutic Products
Drugs to be Discontinued
National Drug Code (NDC) Directory (Updated 4/6/2005). The National Drug
Code (NDC) System was originally established as an essential part of an out-of-
hospital drug reimbursement program under Medicare. The NDC serves as a
universal product identifier for human drugs. The current edition of the National
Drug Code Directory is limited to prescription drugs and a few selected OTC
products.
Inactive Ingredient Database The database provides information on inactive
ingredients present in FDA-approved drug products. This information can be
used by industry as an aid in developing drug products.
Index to Drug-Specific Information Provides links to Consumer, Patient, and
Healthcare Professional Sheets, and more.


2.3 Drug Information Pathfinder

Drug Information Pathfinder-Provides links to information on
specific drugs, drug development, drug application process, drug
imports, and other topics.


2.4 Consumer Drug Information
Index to Drug-Specific Information Provides links to Consumer,
Patient, and Healthcare Professional Sheets, and more.
Antimicrobial Resistance Page
Common Drugs of Abuse: Marijuana. Information from the National
Institute on Drug Abuse.
Consumer Education: What You Should Know About Buying and
Using Drug Products
Beef Insulin: Frequently Asked Questions about Importing Beef Insulin
for Personal Use
Drug Shortages
Generic Drugs: Questions and Answers
How To Obtain Domperidone
Influenza Antiviral Drugs and Related Information
Metered-Dose Inhalers (MDIs)


2.5 Over-the-Counter Drug Information

Over-the-Counter Drug Page- Information for consumers and industry
about non-prescription drugs.


2.6 Drug Safety & Side Effects
Index to Drug-Specific Information Provides links to Consumer, Patient, and
Healthcare Professional Sheets, and more.
Accutane (isotretinoin): A Letter to Consumers and Health Care Providers
Adverse Events Reporting System
AERS Electronic Submissions
Clozapine Issue Paper
FDA Medical Bulletin -Important Information for Health Professionals from
the U.S. Food and Drug Administration.
FDA Statement on the Results of the Women's Health Initiative
Labeling Changes Related to Drug Safety- The summaries include only those
safety-related sections that have been modified, and therefore do not contain all
the information needed for safe and effective prescribing. Contact the
manufacturer for the complete labeling/package insert.
Labeling Review Branch-This organization unit page contains recent labeling
updates.
Medication Errors Web Page


2.6 Drug Safety & Side Effects
MedWatch - The web site for the FDA Medical Products Reporting Program.
Miconazole Vaginal Cream and Suppositories Safety Information -FDA updates safety
information for Miconazole vaginal cream and suppositories. FDA advises women who take the
prescription blood thinner warfarin to consult their doctor or pharmacist for advice before using
over-the-counter miconazole vaginal products. Using the two products together could cause
bleeding or bruising.
Patient Safety- Final Summary of Food and Drug Administration (FDA) Action Items - Doing
What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact
Preventable Adverse Drug Reactions: A Focus on Drug Interactions
Protease Inhibitors Backgrounder -Protease inhibitors are members of a class of antiretrovirals
that are generally considered to be the most potent therapeutic agents for HIV to date. In order
for these drugs to be effective and to minimize the risk of resistance, it is important that these
drugs are prescribed and taken in accordance with the products' approved labeling.
Reporting Adverse Reactions and Other Problems with Products Regulated by FDA-
Consumers can play an important public health role by reporting to the U.S. Food and Drug
Administration any adverse reactions or other problems with products the agency regulates.
Safety of Sodium Phosphates Oral Solution
Visicol: Science Backgrounder: Seizure Associated with the Use of Visicol for Colonoscopy -
Additional Information


2.7 Drug Preparedness and Bioterrorism
Response

Drug Preparedness and Bioterrorism Response


2.8 Clinical Trials Information
Information for Clinical Investigators
Participation of Racial/Ethnic Groups in Clinical Trials and
Race-Related Labeling: A Review of New Molecular Entities
Approved 1995-1999.
ClinicalTrials.Gov - This source provides patients, families
and members of the public easy access to information about the
location of clinical trials, their design and purpose, criteria for
participation, and, in many cases, further information about the
disease and treatment under study.
Cancer Clinical Trials Listing -This is an alphabetical listing
of cancer organizations with extensive information about cancer
treatments and clinical trials.


2.9 Public Health Alerts & Warning Letters

Public Health Advisories, 1997 to Present
Alcohol Warnings for Pain Relievers and Fever Reducers
Class Labeling for Intranasal and Orally Inhaled
Corticosteroid Containing Drug Products Regarding the
Potential for Growth Suppression in Children


Warning Letter Index
Company Date Issuing Subject File Response
Name Warning Office Posted
Letter
Issued
Pfizer Inc. 4/13/05 CDER Labeling/Prom PDF/HTML NO
otional Claims
False &
Misleading/Mis
branded
Ranbaxy 10/11/02 CDER Certain Drugs PDF/HTML NO
Pharmaceu Accord New
ticals Inc. Drug Status
through
Rulemaking
Procedures/Gua
ifenesin

2.10 Reports & Publications
CDER Guide to Median Approval Time Statistics
Drug Master Files
Drug Registration and Listing System Instruction Booklet
Evaluation of Written Prescription Information Provided in Community
Pharmacies, 2001
FDA Consumer Special Issue - From Test Tube to Patient
FDA's Drug Review and Approval Times


2.11 Special Projects & Programs

AIDS Information- Offering the latest federally approved information on research,
clinical trials, and treatment for patients and health care providers. (External Site)
Analgesia and Anti-inflammatory Drug Information
Antiretroviral HIV Drug Approvals and Pediatric Labeling Information- This chart
lists the drug name, company, adult approval date, and pediatric approval date (if
appropriate).
Botanical Review Team (Botanical Drug Product Development)
Cancer Drug Approval Endpoints: FDA Project and Meeting Information.
FDA Oncology Tools. Oncology Tools contains a variety of information related to
cancer and approved cancer drug therapies
Pediatric Drug Development
Pharmaceutical cGMPs: A Risk-Based Approach
Postmarketing Study Commitments
Process Analytical Technologies (PAT)


3. REGULATORY GUIDANCES
3.1 Regulatory & Scientific Guidances
3.2 Specific Regulatory Initiatives
3.3 Legislation
3.4 Submitting Applications for New Drug
Products
3.5 International Activities
3.6 CDER Policies & Procedures
3.7 Compliance Activities
3.8 Freedom of Information Act
3.9 Useful Resources


4. CDER CALENDER
4.1 Advisory Committee Meetings
4.2 Meetings, Conferences & Workshops
4.3 CDER News (CDER’s small business workshop in Kansas City)


5. SPECIFIC AUDIENCES
5.1 Consumer & Patient Information - General
Information (example- Consumer education)
5.2 Consumer & Patient Information - Drug
Information (Over-the-Counter Medicines: What’s
right for you)
5.3 Consumer & Patient Information - Adverse
Reactions & Warnings
5.4 Freedom of Information
5.5 International Activities
5.6 Pediatrics
5.7 Small Businesses
5.8 Spanish Speaking Audiences


6. CDER ARCHIVES
Official records, older publications and superseded but still
useful information. This classification is currently under
development and is not comprehensive

6.1 Drug Information Approved Prior to 1998
6.2 Superseded Guidances
6.3 Archival Reports & Publications (Annual Adverse
Drug Experience Report )


www.fda.gov/cder
www.accessdata.fda.gov/scripts/wlcfm/issuer.cf
m?ISSUER=Center%20for%20Drug%20Evaluat
ion%20and%20Research

What is the goal of “OTC Drug Review Program”? (2 marks)
What is included in “Drug Information”? (2 marks)
What is included in “Specific Audiences” and “CDER
Archives” (2 marks)
Write a note on Over-the-counter Drug Review Process.
(5 marks)
Write a note on “Communicating with CDER” and “Other
Activities” (5 marks)

Write a note on New Drug Development and Review.
(8 marks)
Write a note on Post Drug Approval Activities. (10 marks)

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