U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) introduce the bipartisan Verifying Accurate, Leading-edge IVCT Development Act that is intend...
Hikma Pharmaceuticals extends a previously announced recall of certain lots of ketorolac tromethamine injection USP 30mg/mL, 1mL fill/2mL vials due to...
FDA warns Reproductive Technologies about significant deviations from regulations for human cells, tissues, and cellular and tissue-based products.
Federal Register notice: FDA withdraws its 2006 guidance entitled Exocrine Pancreatic Insufficiency Drug Products Submitting NDAs.
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Neurocrine Biosciences Ingrezza (valbenazine to...
Federal Register notice: FDA makes available a guidance entitled The Deemed To Be a License Provision of the BPCI Act: Questions and Answers.
Stericycle says drug and medical device manufacturers will likely see more government regulatory activity from FDA and other agencies in 2020.
FDA publishes a revised guidance on identifying and characterizing drug metabolites whose nonclinical toxicity needs to be evaluated.