The FDA Office of Clinical Pharmacology issues its 2021 annual report with an outlook for 2022.
FDA suspends enrollment of new patients in all Ukoniq trials while it evaluates a potential risk of increased death seen in the UNITY trial.
Federal Register notice: FDA withdraws a 7/14/2011 proposed rule entitled Removal of Certain Requirements Related to the Prescription Drug Marketing A...
Federal Register notice: FDA proposes to amend certain prescription drug marketing regulations to reflect changes to affected provisions of the Federa...
CDRH releases its strategic priorities for 2022-2025.
FDA proposes a rule for national standards to license wholesale drug distributors and third-party logistics providers.
Hogan Lovells attorneys say FDA has difficult decisions ahead to implement an 11th Circuit Court of Appeals decision against the agencys established p...
FDA tells a House user fee reauthorization hearing that it is enthusiastic about new early interaction meetings for getting feedback on drug developme...