Hi-Tech Pharmaceuticals accuses FDA of bullying it into withdrawing its dietary supplements containing DMHA.
Biopharmadive says PhRMA members are responding in varying ways to the associations call for voluntary inclusion of some drug cost information in dire...
Medical device consultants Cognition describes efforts by FDA to harmonize design control regulations with a new ISO medical device quality management...
FDA and university researchers publish a BioCompute Object Specification document.
Public Citizen asks FDA to require a Boxed Warning and revised REMS warning of the risk of spinal fractures if patients stop taking Amgens Prolia for ...
FDA warns Malaysias Luen Fook Medicine about CGMP violations in its production of an unapproved new drug.
FDA warns RIJ Pharmaceutical about CGMP violations in its production of finished drugs.
FDA stops sales and distribution of surgical mesh products made by Boston Scientific and Coloplast indicated for transvaginal repair of pelvic organ p...