RXQ Compounding recalls all sterile human and animal products within expiry due to a lack of sterility process assurance associated with sterile produ...
Imarc lists seven causes of non-compliant studies found in FY 2017 FDA Bioresearch Monitoring inspections.
GE Healthcare recalls all Giraffe Warmers and Panda iRes Infant Warmers because bedside panels and latch areas on beds may crack, break or become dama...
Federal Register notice: FDA extends the comment period until 7/16 that seeks input and scientific data about the safety, manufacturing, product quali...
Federal Register notice: FDA seeks comments on an information collection extension entitled Format and Content Requirements for Over-the-Counter Drug ...
Bottle of Lies author Katherine Eban says she finds it disturbing that FDA supervisors are downgrading the severity of foreign inspection findings and...
Five drug companies comment on an FDA draft guidance on bispecific antibody development.
FDA says it will use enforcement discretion to not act against certain food or dietary supplement health claims for omega-3 fatty acids.