FDA warns Banten, Indonesia-based P.T. Sankei Medical Industries about Quality System and Medical Device Reporting violations in the manufacturing of ...
FDA approves an Aquestive Therapeutics ANDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of freq...
FDA clears a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac joint fusion construct.
Federal Register notice: FDA makes available a draft guidance entitled Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public...
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Section 564 Declared E...
AdvaMed calls for updates to FDA and HHS informed consent guidances.
FDA approves Boehringer Ingelheims high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Abbvies...
The National Community Pharmacists Association raises several categories of concerns with FDA in advance of the agencys annual drug compounding listen...
