FDA Related News

Federal Register

Info Collection on Humanitarian Use Devices

Federal Register notice: FDA seeks comments on an information collection entitled Medical Devices; Humanitarian Use Devices (HUD) 21 CFR Part 814.

Federal Register

Info Collection on E-Records/E-Signatures

Federal Register notice: FDA seeks comments on an information collection extension for electronic records and signatures.

FDA General

Docs Should Reassure Covid Patients About FDA: Hahn

FDA commissioner Stephen Hahn tries to reassure healthcare professionals that the agency is sticking to science and not cutting corners in its decisio...

Lantheus/Progenics sNDA Approved for Vialmix RFID

FDA approves a Lantheus and Progenics Pharmaceuticals supplemental NDA for Vialmix RFID for Definity.

Human Drugs

Alert on Compounded Moxifloxacin Ophthalmic Solutions

An FDA drug safety alert warns about reports of toxic anterior segment syndrome following intraocular administration of compounded drugs using moxiflo...

Medical Devices

MagVenture TMS Therapy Cleared for OCD

FDA clears a MagVenture 510(k) for its TMS Therapy as an adjunct treatment for obsessive-compulsive disorder.

Human Drugs

FDA Accepts Regeneron BLA for Priority Review

FDA says it will give priority review to Regenerons BLA for evinacumab as an adjunct treatment in patients with homozygous familial hypercholesterolem...

Federal Register

Vaccines Panel to Discuss 2021 Flu Vaccine

Federal Register notice: FDA announces a 10/2 Vaccines and Related Biological Products Advisory Committee meeting that will discuss 2021 flu vaccine.

Federal Register

Marketing Status Notifications Guidance

Federal Register notice: FDA makes available a final guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, an...

Human Drugs

FDA Finds Multiple Violations in Mexican Hand Sanitizers

FDA warns Mexicos Soluciones Cosmeticas that it distributed unapproved adulterated and misbranded hand sanitizers that contained methanol.