Study Data Technical Conformance Guide – Technical Specifications Document
This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.
Category: US National Health Agency Sources
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Seraclone Blood Grouping Reagents and Anti-Human Globulin Reagents (STN# 125213, 125215, 125217, 125219 – 125233, 125242)
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 …
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…
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 …