Three Benesh Friedlander Coplan & Aronoff attorneys say a suit against FDA filed by the Alliance for Natural Health USA could change the way that supp...
FDA publishes a guidance notifying blood establishments about agency recommendations for screening and deferring blood donors in response to an Ebola ...
FDA warns Excelvision about CGMP violations in the production of drugs at its facility in Annonay, France.
FDA warns Genzyme Ireland about the failure of the firms quality control unit to ensure that drugs comply with CGMP requirements.
FDA says the Abiomed recall of certain Impella CP Sets with SmartAssist is Class 1.
FDA says an Insulet recall of specific lots of its Omnipod Pods is Class 1.
FDA selects seven companies from 80 applications to participate in the agencys PreCheck Pilot Program to advance U.S. drug manufacturing.
FDA publishes a guidance on submitting next-generation sequencing data to CDERs Division of Antivirals.