Federal Register notice: FDA posts a draft guidance entitled Post-Warning Letter Meetings Under GDUFA.
Federal Register notice: FDA withdraws 35 no-longer-marketed NDAs from multiple applicants.
Federal Register notice: FDA announces a public meeting to discuss proposed recommendations for the reauthorization of the Over-the-Counter Monograph ...
FDA warns South Koreas Green Pharmaceutical Co. in Jincheon about CGMP violations in its manufacturing of over-the-counter drugs.
FDA publishes an updated guidance on standards for the interoperable exchange of information for tracing certain drugs under the Drug Supply Chain Sec...
FDA posts recommendations for healthcare providers, medical device manufacturers, and distributors on best practices in preparing for natural disaster...
FDA grants Xenex Disinfection Services a de novo marketing authorization for the companys LightStrike+ device, a broad-spectrum ultraviolet light robo...
Individuals and organizations opposed to using puberty blockers in gender identity treatment for minors ask FDA to take several steps to increase know...
