Federal Register final rule: FDA rules that certain active ingredients are not allowed to be used in OTC hand sanitizers.
FDA publishes its finalized list of medical device accessories eligible for Class 1 distinct from other devices.
FDA clears a CivCo Radiotherapy 510(k) for its GrayDuck Stents, which are intended to provide custom oral positioning with repeatable tongue deviation...
Two stakeholders offer recommendations to clarify an FDA draft guidance on voluntary consensus standards relating to drug quality.
Immuron says it is planning to develop and seek FDA approval for IMM-124E, its bovine polyclonal antibody drug candidate for preventing travelers diar...
A Florida federal court denies an Apotex motion seeking to dismiss the latest Amgen patent suit over Apotex biosimilar Neupogen and Neulasta products....
Takara Bio files a Drug Master File to FDA for the liquid formulation of RetroNectin GMP grade.
FDA clears an Elucent Medical 510(k) for the EnVisio Surgical Navigation System to identify the location of the tissue to be removed.