Adverse Events Home Page
IND Decision Tool
IND Exemption Form
Introduction
Highlights of FDA History
FDA vs. OHRP
What FDA Regulates
FDA Authorities
FDA Centers
Clarifying the "new" in IND
Assessing Preclinical Data
Properties of the Study Drug
How the Data is Used
IND Submission
IND Holder Reponsibilities

FDA Centers

Currently, the FDA is divided into 5 centers relevant to clinical research. Each of these centers regulates different types of products.

CDER
Center for Drug Evaluation and Research
All drug products.

CBER
Center for Biologics Evaluation and Research
Biological products such as vaccines, blood, cellular & gene therapy, allergenics, and tissues.

CDHR
Center for Devices and Radiological Health
Medical devices and radiation-emitting electronic products,

CVM
Center for Veterinary Medicine
Food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals.

CFSAN
Center for Food Safety and Applied Nutrition
Foodborne illness, nutrition, dietary supplements, all food products except for meat, poultry and some egg products