FDA Roundup: March 7, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format
Guidance for Industry – Labeling
Radioactive Drug Research Committee (RDRC) Program
Regulating the use of radioactive drugs in basic research
Activities Report of the Generic Drug Program (FY 2024) – FDARA Title VIII Sections 807 and 805
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug…
Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug…
Frequently Requested or Proactively Posted Compliance Records
Frequently requested inspection records of foreign pharmaceutical manufacturing facilities
Berkeley Nutritional Mfg Corp. – 500324 – 01/31/2017
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
NutraCore Health Products – 542906 – 09/11/2018
Close Out Letter
Choice Detox Center, Inc. dba Nofeel – 543456 – 09/11/2018
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Best Bentonite – 494502 – 11/23/2018
Unapproved New Drugs/Misbranded