The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.

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