Federal Register notice: FDA announces a 9/9 Antimicrobial Drugs Advisory Committee meeting to discuss an Iterum Therapeutics NDA for its urinary trac...
Federal Register notice: FDA reopens the comment period for its proposed administrative order entitled Amending Over-the-Counter Monograph M013: Inter...
The CDER Office of Prescription Drug Promotion releases plans to survey 2,400 healthcare providers on several issues relating to prescription drug pro...
FDA approves a Servier Pharmaceuticals NDA for Voranigo (vorasidenib) for treating certain adult and pediatric patients 12 years and older with Grade ...
CDER compliance officer Yasamin Ameri says FDA will issue about the same number of drug CGMP Warning Letters in 2024 as in 2023.
Spark Biomedical, a manufacturer of an FDA-approved neurostimulation device, asks the agency to ensure that unapproved neurostimulation devices meet t...
The CDER Office of Prescription Drug Promotion says a Mirati Therapeutics provider Web page for Krazati makes false and misleading efficacy claims for...
BeiGene says that due to inspection scheduling issues, FDA has deferred approval for Tevimbra (tislelizumab) in first-line unresectable, recurrent, lo...
