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 (IND) or Device Exemption (IDE) Process (CBER) 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).
- 510(k) Process (CBER) A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters...
- Premarket Approval (PMA) Process (CBER) Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in...
- New Drug Application (NDA) Process (CBER) New Drug Applications (NDAs) are regulated under 21 CFR 314
- Regulatory Submissions in Electronic Format for Biologic Products
- Resources for You
- Recalls & Alerts
- Approvals & Clearances