FDA Related News

Clinical Trial Diversity Bill Introduced

Three Congressional representatives introduce bipartisan legislation intended to increase diversity in clinical trials.

Human Drugs

Pfizer, Ionis Bail on Vupanorsen Development

Pfizer and Ionis say they are discontinuing a development program for vupanorsen for potential cardiovascular risk reduction.

Human Drugs

Clinical Pharmacology Report Out

The FDA Office of Clinical Pharmacology issues its 2021 annual report with an outlook for 2022.

Human Drugs

FDA Looking at Ukoniq Death Risk

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

FDA Nixes 2011 Proposal on Drug Supply Security

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

Proposed Rule on Wholesale Drug Distributors

Federal Register notice: FDA proposes to amend certain prescription drug marketing regulations to reflect changes to affected provisions of the Federa...

Medical Devices

CDRH 2022-2025 Strategic Priorities

CDRH releases its strategic priorities for 2022-2025.

Human Drugs

Drug Distributor National Standards Rule

FDA proposes a rule for national standards to license wholesale drug distributors and third-party logistics providers.

Human Drugs

11th Circuit Threatens FDA Orphan Drug Decisions: Attorneys

Hogan Lovells attorneys say FDA has difficult decisions ahead to implement an 11th Circuit Court of Appeals decision against the agencys established p...

FDA General

FDA Likes New User Fee Interactions, and Resources: Hearing

FDA tells a House user fee reauthorization hearing that it is enthusiastic about new early interaction meetings for getting feedback on drug developme...