Biologic License Applications
Investigational New Drug Applications
New Drug Applications
OTC Drug Applications
Center for Drug Evaluation and Research (CDER)
The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.
CDER is the largest of FDA's six centers. It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs. For more information on CDER activities, including performance of drug reviews, post-marketing risk assessment, and other highlights, please see About the Center for Drug Evaluation and Research. The other five FDA centers have responsibility for medical and radiological devices, food and cosmetics, biologics, veterinary drugs, and tobacco products.
Code of Federal Regulations (CFR)
1) National Drug Code Directory
2) First Generic Drug Approvals
4) Orange Book (Therapeutic Equivalents)
5) Clinical Researchers
Drug and Biologic Approval and Investigational New Drug Activity Reports
This list includes new drug application (NDA), biologic license application (BLA), and abbreviated new drug application (ANDA) approvals. The list also includes a link to investigational new drug (IND) activity reports.
Fast Track Designation Requests
Food and Drug Administration
Ingredients and Appearance
National Drug Code
National Drug Code Directory
The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.
The information submitted as part of the listing process, the NDC number, and the NDC Directory are used in the implementation and enforcement of the Act.