FDA denies a petition seeking a prescription to OTC switch of oral contraceptives.
FDA denies a Par petition asking it to require that applicants for generic Adrenalin injection have the same inactive ingredients in the same concentr...
Federal Register Notice: FDA makes available draft guidance #242 entitled In-Use Stability Studies and Associated Labeling Statements for Multiple-Dos...
FDA Webview editor Jim Dickinson analyzes CDRHs failure to exercise its statutory authority to regulate violative medical device advertising and promo...
FDA posts a guidance on ANDA Submissions Refuse-to-Receive Standards that is intended to assist applicants preparing to submit ANDAs and prior approv...
FDA issues a guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.
FDA Webview editor Jim Dickinson analyzes FDAs readiness for President Trump and predicts that when he turns his attention to the agency, hell likely ...
Barnes & Thornburg attorneys outline provisions in an FDA final guidance on evaluating and communicating medical device emerging signals.