GUIDANCE : Centre For Drug Evaluation And Research (U.S. Requirement)

1. CENTRE FOR DRUG
EVALUATION AND RESEARCH
(CDER)
Presented By : Mahesh Ashok Marathe
Department : Pharmaceutics (Sem-2) ,
Sinhgad college of pharmacy ,vadgaon
Roll no. : 514

2. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION (FDA)
Center for
Drug
Evaluation &
Research
(CDER)
Center for
Biologics
Evaluation &
Research
(CBER)
Center for
Devices &
Radiological
Health
(CDRH)
Center for Food
Safety &
Applied
Nutrition
(CFSAN)
Center for
Veterinary
Medicine
(CVM)
National Center
for
Toxicological
Research
Office of the
Commissioner
Office of
Regulatory
Affairs
Mission…..??

3.  CDER’s mission is to protect and promote public
health by helping to ensure that human drugs are
safe and effective for their intended use.
 To protect public health by promoting the safe use
of marketed drugs and by helping to ensure the
quality and integrity of marketed drug products.

4. • Promote public health by ensuring the availability of
safe and effective drugs : Promote patient and health
professional awareness of drug benefits and risks
through effective communication of drug information
• Protect public health by promoting the safe use of
marketed drugs: Oversee drug promotion and marketing
to help ensure that marketed drug labeling and
advertising are truthful and not misleading
• Protect public health by ensuring the quality and
integrity of marketed drug products
4
FUNDAMENTAL GOALS AND OBJECTIVES

5. CURRENT CDER ACTIVITY
 To oversee new drug development and review of drug
marketing applications.
 To oversee post-marketing drug safety, to help ensure
safe use of approved medicines
 To oversee drug manufacturing and quality.

6.  CDER assures that all prescription and over-the-
counter drugs are safe and effective.
 Efficient risk management
 Provides health professionals and consumers
information to use drugs appropriately and
safely.(ads, communication media)
 Remove barriers to innovation in drug development
and to facilitate the modernization of drug
manufacturing.
OTHER ROLES

7. WORK OF CDER
 CDER Drug Product Applications
 CDER Small Business Assistance Program
 Small business guide to FDA
 CDER Handbook
describes the Center's processes and activities
 New Drug Development and Review
- IND, NDA
 Generic Drug Review –ANDA
Over-the-Counter Drug Review
Post Drug Approval Activities.
Communicating with CDER
Other activities

8. REGULATORY GUIDANCES
3.1 Regulatory & Scientific Guidances
3.2 Submitting Applications for New Drug
Products
3.4 International Activities
3.5 CDER Policies & Procedures
3.6 Compliance Activities
3.7 Useful Resources

9. Current Guidance Agenda
..DesktopGuidance Agenda
2017_2017.02.15.pdf

12. www.fda.gov/RegulatoryInformation/Gui
dances/default.htm Access on 21/2/2017
www.fda.gov/cder