Federal Register notice: FDA seeks comments on an information collection extension on the Guidance for Industry on Postmarketing Adverse Event Reporti...
FDA sends Warning Letters to four companies that marketed marijuana-derived products as cancer treatments.
Federal Register notice: FDA seeks comments on an information collection extension on Postmarketing Safety Reports for Human Drug and Biological Produ...
Federal Register notice: FDA makes available a guidance entitled Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients...
FDA warns Indias Kim Chemicals about CGMP and other violations in its manufacturing of OTC products.
An FDA safety update says that interim study results from a pivotal clinical trial continue to show an increased rate of major adverse cardiac events ...
FDA warns Accelerated Analytical Laboratories about CGMP violations at its drug manufacturing facility.
FDA says it will recognize drug manufacturing inspections from eight European countries, avoiding duplication of inspections and resources.