Product approval information is indicated for the determination of the blood group antigens on red blood cells and detecting in vivo and /or in vitro coating of red blood cells using the tube test.

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.

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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). FDA is committed to…

Products that are regulated as Biologics License Applications (BLAs), New Drug Applications (NDAS), Premarket Approvals (PMAs), and 510(k)s.

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 As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer valid. If you find a link that does not work, please…

CBER carries out a wide range of compliance and surveillance activities during the “life cycle” of biological products

CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for…

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.

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.