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An FDA safety alert warns against the use of certain surgical N95 respirators manufactured by O&M Halyard due to protection failur...[ Price : $8.95]
FDA clears an Avation Medical 510(k) for Vivally, a bladder control therapy device and mobile application for treating patients wi...[ Price : $8.95]
FDA posts a draft guidance entitled A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers.[ Price : $8.95]
FDA places a partial clinical hold on a Molecular Templates Phase 1 study of MT-0169 based on previously disclosed cardiac adverse...[ Price : $8.95]
FDA stakeholders suggest ways for FDA to improve its biosimilar regulatory research roadmap.[ Price : $8.95]
FDA warns Ahmedabad, India-based Champaklal Maganlal Homeo Pharmacy about CGMP violations in its manufacturing of over-the-counter...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America suggests the International Council for Harmonization make changes to its M13A...[ Price : $8.95]
The directors of the CDER Office of Translational Sciences and Office of Communications explain their joint pilot program for guid...