The CDER Office of Prescription Drug Promotion sends a notice of violation to Aclaris for a video and associated materials that it says minimizes the ...
Opko Health submits a de novo request to FDA seeking regulatory clearance for the 4Kscore, a blood test for intended use by health care professionals ...
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...