FDA places a partial clinical hold on a Molecular Templates Phase 1 study of MT-0169 based on previously disclosed cardiac adverse events in two patie...
FDA stakeholders suggest ways for FDA to improve its biosimilar regulatory research roadmap.
FDA warns Ahmedabad, India-based Champaklal Maganlal Homeo Pharmacy about CGMP violations in its manufacturing of over-the-counter and homeopathic dru...
Pharmaceutical Research and Manufacturers of America suggests the International Council for Harmonization make changes to its M13A draft guidance on b...
The directors of the CDER Office of Translational Sciences and Office of Communications explain their joint pilot program for guidance snapshots and p...
Federal Register notice: FDA seeks comments on an information collection revision entitled Generic Drug User Fee Program; Controlled Correspondence.
Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Devices; Reports of Corrections and Removals 21 CF...
Federal Register notice: FDA seeks comments on an information collection revision entitled Investigational New Drug Application Requirements.
