FDA Related News

Human Drugs

Drug Trial Demographic Info Reported

FDA publishes a report summarizing demographic information from pivotal trials supporting 46 novel new drugs approved in 2025.

Human Drugs

Nicotine Dependence NDA Gets Complete Response Letter

FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.

Human Drugs

Pharmaneek Inspection Form FDA-483 Out

FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility in Indianapolis, IN.

Medical Devices

FDA Nixes Enforcement Action Against Whoop's Blood Pressure Feature

FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about whether the company...

Human Drugs

Expand Real-World Evidence Use in Drug Approvals: Article

Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.

Human Drugs

Jubilant HollisterStier CGMP Issues

FDA warns Canadas Jubilant HollisterStier General Partnership about CGMP violations in its manufacturing of finished drugs.

Human Drugs

4 CGMP Violations in Huons Inspection

FDA warns South Koreas Huons Co. about CGMP violations in its manufacturing of finished drugs.

FDA Leadership Upheaval Yields Uncertainty: Post

A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.

Medical Devices

FDA Issues Early Alert on Abiomed Impella Introducer Kits

FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used with Impella heart pu...