FDA publishes two updated draft guidances with current information on aspects of drug transdermal and topical delivery systems to promote the developm...
In two appellate briefs, plaintiffs and defendants argue over jurisdiction issues in their legal fight involving the abortion drug mifepristone (Mifep...
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FDA posts a draft guidance entitled A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers.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...
