Three stakeholders say FDA should provide additional clarification on the rules for listing patents in the Orange Book.
Federal Register notice: FDA determines that KV Pharmaceuticalֺs Micro-K LS (potassium chloride) extended-release liquid suspension, 20 milliequ...
Federal Register notice: FDA corrects a 5/14 Federal Register notice on 16 NDA withdrawals from multiple applicants.
Federal Register notice: FDA establishes a public docket to collect comments related to post-marketing pediatric-focused safety reviews of products po...
FDA denies two of three requests from a petition challenging the clearance and approval of certain nitric oxide products.
FDA says three of four problem scenarios described by Becton Dickinson in its recall of Alaris infusion pumps are Class 1.
President Trump says drug company executives are coming to see him this week and he expects a major cut in prescription drug prices.
FDA warns Mylan about CGMP deviations in producing active pharmaceutical ingredients at one of its facilities in India.