FDA sends Eton Pharmaceuticals a second complete response letter on its NDA for dehydrated alcohol injection for treating methanol poisoning.
Federal Register notice: FDA makes available a draft guidance entitled Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Co...
FDA releases the form FDA-483 with four observations issued following an inspection at the Prisma Health outsourcing facility in Simpsonville, SC.
Federal Register notice: FDA makes available a final guidance entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DT...
FDA issues an Import Alert against all drugs from Chinas Chengdu KeCheng Fine Chemicals and a Warning Letter about its continuing failure to respond t...
Eli Lilly says new Phase 2 data on weight-loss candidate retatrutide met primary and secondary endpoints.
Federal Register notice: FDA sends to OMB an information collection revision entitled Imports and Electronic Import Entries.
Federal Register notice: FDA withdraws the approval of a Gemini Laboratories NDA for Oxandrin (oxandrolone) tablets and four ANDAs that reference the ...
