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Last updated about 20 hours ago
Advertising & Promotional Labeling Questions and Answers
about 20 hours ago
Advertising & Promotional Labeling Questions and Answers
Postapproval Pregnancy Safety Studies
1 day ago
This guidance provides sponsors and investigators with recommendations on how to design...
DUCORD
2 days ago
For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction...
Vaccines and Related Biological Products Advisory Committee May 28, 2026 Meeting Announcement - 05/28/2026
3 days ago
On May 28, 2026, the Committee will meet in open session to...
Drugs@FDA Data Files
3 days ago
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship...
Recently Issued Guidance Documents
4 days ago
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
What’s New for Biologics
4 days ago
Latest news from the Center for Biologics Evaluation and Research
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application
4 days ago
This is the guidance of industry, Chemistry, Manufacturing, and Controls Flexibilities for...
BK261343- Biowy Multi-Chamber Freezing Bag Set
4 days ago
The Biowy Freezing Bag Set is intended for a single sequence of...
Is It Really 'FDA Approved'?
5 days ago
The FDA is responsible for protecting public health by regulating human drugs...