FDA releases its latest batch of Warning Letters that includes B. Braun Medical, Med-Pharmex, Morhaim Pharmalab and Ocubright Tear Stain Remover, Inc.
Federal Register notice: FDA seeks comments on an information collection extension for Electronic Submission Process for Voluntary Allegations to the ...
FDA sends Sunovion Pharmaceuticals a Complete Response Letter on its NDA for SUN-101/eFlow (glycopyrrolate), indicated for treating chronic obstructiv...
FDA says AstraZeneca is recalling one specific lot of Brinilta physician sample bottles after one was found with an additional drug in it.
FDA clears a Masimo 510(k) for a pediatric indication for its O3 regional oximetry with an O3 pediatric sensor.
Amgen sues to force FDA to grant it pediatric exclusivity for its thyroid drug Sensipar.
FDA Review posts Federal Register notices for the week ending 5/26/2017.
The House Energy and Commerce Committee asks for additional information from NIH to verify corrections and the resolution of clinical research complia...