International Academy of Compounding Pharmacists executive Scott Brunner calls on FDA to revises the way it is implementing the Drug Quality and Secur...
FDA says it is developing new tools to aid in evaluating peptides and their generic alternatives.
Stakeholders comment on potential changes to an FDA benefit/risk evaluation assessment framework.
FDA approves a Philips PMA application for two defibrillators and related accessories.
CDER director Janet Woodcock asks Congress for statutory improvements to its citizen petitions process and the 180-day exclusivity available to ANDA f...
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...