Federal Register notice: FDA debars Robert Richard Jodoin for five years from importing any drug into the U.S. after being convicted for importing a c...
FDA releases its latest batch of Warning Letters that includes Cipla Limited, Gojo Industries and Windlas Healthcare Private Limited.
Novo Nordisk stops two clinical trials in its concizumab Phase 3 development program and one clinical trial in the Phase 2 program due to safety issue...
FDA adds three questions to its FAQs on developing Covid-19 diagnostics.
FDA approves safety labeling changes for four SGLT2 inhibitors to recommend that their use be temporarily discontinued several days before planned sur...
Federal Register notice: FDA makes available a final guidance on drugs for slowly progressive, low-prevalence rare diseases with substrate deposition.
Federal Register notice: FDA extends the comment period on a draft guidance entitled Drug Products Labeled as Homeopathic.
Federal Register notice: FDA makes available a final guidance entitled Competitive Generic Therapies.