FDA revises a 2015 draft guidance on Gastroparesis: Clinical Evaluation of Drugs for Treatment.
Federal Register notice: FDA sends to OMB an information collection extension for its guidance on medical device accessories.
The Stericycle Recall Index says drug recalls are dropping but the number of recalled units is increasing, while medical device recalls and units are ...
FDA says it will start inactivating drug listing records that are improperly listed according to agency requirements.
FDA warns Talon about Quality System and other violations in its production of Class 1 and 2 medical devices.
FDA warns Indias Emcure Pharmaceuticals about a CGMP issue in its production of finished pharmaceuticals.
FDA says further study has indicated no increased risk of prostate cancer for users of Comtan or Stalevo to treat Parkinsons disease.
Dalhousie University professor Matthew Herder says FDA appears resigned to and resistant to criticism of its increasing regulatory reliance on postmar...