FDA Related News

Bipartisan Real-World Evidence Legislation Introduced

Sens. Marshall, Smith, and Cassidy introduce bipartisan legislation to enable FDA to develop a framework for using real-world evidence gathered from e...

FDA General

FDA Scenarios for Future Inspections

FDA acting commissioner Janet Woodcock says the agency is developing various scenarios for moving back to standard inspection operations.

Human Drugs

Pfizer Reports Elranatamab Hiccup on New Study

Pfizer pauses enrollment in a registration-enabling Phase 2 study of elranatamab after FDA requested additional data on three cases of peripheral neur...

Human Drugs

ViiV Rolling NDA for HIV Prevention Drug

ViiV Healthcare begins a rolling NDA submission for cabotegravir, a long-acting, injectable drug for preventing HIV.

Medical Devices

Exempt Power Patient Transport from 510(k): Stryker

Stryker petitions FDA to exempt powered patient transport from 510(k) premarket notification.

Human Drugs

Siga Technologies NDA for IV Tpoxx

Siga Technologies files an NDA for Tpoxx (tecovirimat), an intravenous formulation for treating human smallpox disease in adults and pediatric patient...

Human Drugs

Unived Marketing Unapproved Drugs: FDA

FDA warns Unived it is marketing misbranded unapproved new drugs.

Human Drugs

Immune & Genetics Protocols Marketing Unapproved Drug: FDA

FDA warns Immune & Genetics Protocols that it is marketing a misbranded unapproved new drug.

Medical Devices

Workshop on Orthopedic Device Postmarket Duties

FDA announces a 6/10 virtual public workshop on orthopedic device postmarket programs and activities.

Human Drugs

FDA Touts Complex Generic Drug Efforts

Office of Generic Drugs Research and Standards director Robert Lionberger says FDA is taking many steps to promote the development of complex generic ...