Development & Approval Process (CBER)
The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities including the Public Health Service Act and the Food Drug and Cosmetic Act.
- Investigational New Drug Applications (INDs) for CBER-Regulated Products
An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
- Expanded Access to Experimental Biologics
Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA).
- Biologics License Applications (BLA) Process (CBER)
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2).
- Premarket Notification 510(k) Process for CBER-Regulated Products A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device (section 513(i)(1)(A) FD&C Act).
- Premarket Approval (PMA) for CBER-Regulated Products A PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
- New Drug Application (NDA) Process (CBER) New Drug Applications (NDAs) are regulated under 21 CFR 314
- Regulatory Submissions in Electronic Format for CBER-Regulated Products
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
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