CENTRE FOR DRUG EVALUATION AND RESEARCH

(CDER)

Presented By : Mahesh Ashok Marathe

Department : Pharmaceutics (Sem-2) , Sinhgad college of pharmacy ,vadgaon

Roll no. : 514

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…..??

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.

CDER

• 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

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.

CDER assures that all prescription and over-the-counter drugs are safe and effective.

Efficient risk managementProvides 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

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 –ANDAOver-the-Counter Drug ReviewPost Drug Approval Activities. Communicating with CDEROther activities

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

Current Guidance Agenda

..\Desktop\Guidance Agenda 2017_2017.02.15.pdf

www.fda.gov/RegulatoryInformation/Guidances/default.htm

Access on 21/2/2017

REFERENCES

www.fda.gov/cder