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 investigatio…
Author: fda-agency-news
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 ha…
Approved Blood Products
Products that are regulated as Biologics License Applications (BLAs), New Drug Applications (NDAS), Premarket Approvals (PMAs), and 510(k)s.
Other Recommendations for Biologics Manufacturers
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer va…
Compliance Actions (Biologics)
CBER carries out a wide range of compliance and surveillance activities during the "life cycle" of biological products
Industry (Biologics)
CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers …
Pulse Oximeter Basics
A pulse oximeter, or pulse ox, is a device that estimates the amount of oxygen in the blood. Here’s what to know before using one.
FDA Roundup: March 18, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.