FDA warns BioPure Healing Products that its dietary supplements are adulterated and misbranded.
Due to an inspection moratorium, FDA sends Nabriva Therapeutics a complete response letter on its NDA resubmission seeking marketing approval of Conte...
The Informed Consent Action Network petitions FDA to require a saline placebo control group in all Phase 2 or 3 clinical trials of Covid-19 vaccine ca...
Two George Mason University researchers make a case for transferring food regulation from FDA to the Agriculture Department so FDA can better focus on...
Federal Register notice: FDA determines that Promius Pharmas Tenex (guanfacine HCl) tablets, 1mg, 2mg,and 3mg were not withdrawn from sale for reasons...
FDA commissioner Stephen Hahn praises agency medical product review staff for maintaining the pace of reviews and actions during the pandemic.
Democratic leaders of the House Committee on Oversight and Reform ask FDA for a briefing on plans for coronavirus vaccine transparency to build public...
Two SheppardMullin attorneys discuss provisions in an FDA guidance on preventing coronavirus contamination of drugs, biologics, and APIs.