FDA Related News

Human Drugs

ICH Quality Risk Management Guide Adopted by FDA

The International Conference on Harmonization posts a final guide entitled Quality Risk Management Q9 (R1), which has been adopted by FDA for implemen...

Federal Register

Conformity Assessment Program Information Collection

Federal Register notice: FDA seeks comments on an information collection extension entitled Accreditation Scheme for Conformity Assessment Program.

Animal Drugs

Guide on Developing Dog Heartworm Drugs

The agency is seeking public comment on the guidance for 60 days.

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FDA posts a draft guidance entitled Mpox: Development of Drugs and Biological Products.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