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Safety Alert on O&M N95 Respirators

[ Price : $8.95]

An FDA safety alert warns against the use of certain surgical N95 respirators manufactured by O&M Halyard due to protection failur...

Avation Medical Bladder Control Device Cleared

[ Price : $8.95]

FDA clears an Avation Medical 510(k) for Vivally, a bladder control therapy device and mobile application for treating patients wi...

Clinical Trial Monitoring Q & A Guide

[ Price : $8.95]

FDA posts a draft guidance entitled A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers.

Partial Hold on Molecular Templates Study

[ 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...

Suggestions for Biosimilar Research Roadmap

[ Price : $8.95]

FDA stakeholders suggest ways for FDA to improve its biosimilar regulatory research roadmap.

CGMP Issues at Indias Champaklal Pharmacy

[ Price : $8.95]

FDA warns Ahmedabad, India-based Champaklal Maganlal Homeo Pharmacy about CGMP violations in its manufacturing of over-the-counter...

Improve ICH M13A Bioequivalence Guidance: PhRMA

[ Price : $8.95]

Pharmaceutical Research and Manufacturers of America suggests the International Council for Harmonization make changes to its M13A...

FDA Launching Patient Guidance Snapshots

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The directors of the CDER Office of Translational Sciences and Office of Communications explain their joint pilot program for guid...

Info Collection on Generic Drug Correspondence

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision entitled Generic Drug User Fee Program; Controll...

Device Corrections/Removals Info Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision entitled Medical Devices; Reports of Corrections...