Federal Register notice: FDA announces a 10/16 Advisory Committee meeting to review a Shionogi NDA for antibiotic for urinary tract infections.
FDA highlights a new Warning Letter to a Chinese drug manufacturer as evidence of its increased oversight of over-the-counter drug manufacturing.
Federal Register notice: FDA sets a 10/30 advisory committee meeting to review an Agile Therapeutics transdermal contraceptive.
Federal Register notice: FDA announces a pilot program to test the processing and analysis of nonclinical study data provided electronically for the C...
Federal Register notice: FDA corrects a 6/8/2011 notice about the approval withdrawal of 70 NDAs and 97 ANDAs from multiple applicants.
Federal Register notice: FDA plans workshop to provide an update on its predictive toxicology roadmap.
The United States Pharmacopeia sets a 90-day comment period for a proposed policy change relating to publication of reporting thresholds in drug produ...
Sarepta wants to schedule a meeting with FDA to discuss next steps following a complete response letter for its Duchenne muscular dystrophy drug golod...