FDA Related News

Medical Devices

Surmodics SurVeil PMA Not Approvable: FDA

FDA says a Surmodics PMA for its SurVeil drug-coated balloon to treat peripheral artery disease is not currently approvable.

Medical Devices

FDA Amends, Repeals Some Rad Health Regs

FDA publishes a final rule amending and repealing some radiological health regulations.

Biologics

Mpox Product Development Guidance

FDA posts a draft guidance entitled Mpox: Development of Drugs and Biological Products.

Human Drugs

FDA Seeks Injunction Against LGM Pharma

FDA asks a Florida federal court for an injunction against LGM Pharma to ensure that it no longer holds and ships adulterated drugs.

Human Drugs

11 Observations on Intas Pharmaceuticals FDA-483

FDA releases the form FDA-483 with 11 observations from an inspection at Indias Intas Pharmaceuticals.

Medical Devices

Realize Medical Virtual Reality Surgical Tool Cleared

FDA clears a Realize Medical 510(k) for its Elucis virtual reality software for surgical planning.

Fix the Evidence Generation System Now: Califf

FDA commissioner Robert Califf says FDA has a key role to play in reshaping the nations system for generating medical evidence to support new treatmen...

Biologics

Lilly Alzheimers BLA Rejected by FDA

FDA sends Eli Lilly a complete response letter for its accelerated approval BLA submission for donanemab, indicated for treating early symptomatic Alz...

Medical Devices

Info Collection on Device Adverse Event Program

Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Event Program for Medical Devices (Medical Product...

Federal Register

Info Collection on Informed Consent, IRB Role

Federal Register notice: FDA sends to OMB an information collection extension entitled Protection of Human Subjects; Informed Consent; and Institution...