Federal Register notice: FDA determines that Promius Pharmas Tenex (guanfacine HCl) tablets, 1mg, 2mg,and 3mg were not withdrawn from sale for reasons...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.
Hyman, Phelps & McNamara asks FDA to provide examples to clarify specific items in the agencys draft guidance on emergency-use injectors, while the Jo...
FDA approves a Karyopharm Therapeutics supplemental NDA for Xpovio (selinexor), a selective inhibitor of nuclear export compound for treating adult pa...
FDA issues a safety alert on hand sanitizers manufactured by Eskbiochem SA de CV in Mexico due to the potential presence of methanol (wood alcohol).
Senators Bob Casey (D-PA) and Susan Collins (R-ME) introduce the Creating Hope Reauthorization Act (S 4010) that would permanently reauthorize FDAs pe...