An FDA safety alert warns against the use of certain surgical N95 respirators manufactured by O&M Halyard due to protection failures.
FDA clears an Avation Medical 510(k) for Vivally, a bladder control therapy device and mobile application for treating patients with urinary urgency a...
FDA posts a draft guidance entitled A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers.
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Research and Manufacturers of America suggests the International Council for Harmonization make changes to its M13A draft guidance on b...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...
