FDA Related News

Federal Register

Meeting on User Fee Programs Financial Efficiency

Federal Register notice: FDA announces a 6/18 public meeting entitled FDA Public Meeting on Financial Efficiency of Human Drug User Fee Programs.

Medical Devices

Dont Use Antibody Tests After Covid Vaccination: FDA

An FDA safety communication advises against taking an Covid-19 antibody test for those vaccinated with a Covid vaccine.

Medical Devices

Peripheral Atherectomy Device Updated Guidance

FDA issues an updated final guidance on 510(k) submissions for peripheral vascular atherectomy devices.

Medical Devices

Implanted Brain-Computer Interface Device Test Guidance

FDA issues a leapfrog guidance on non-clinical testing and clinical considerations for implanted brain-computer interface devices.

Human Drugs

Guidance on ANDAs for Some Peptides

FDA issues a guidance on ANDA submissions for some highly purified synthetic peptides.

Medical Devices

Glycemic Control Medical Device Guidance

FDA publishes a draft guidance on clinical studies for glycemic control medical devices.

Human Drugs

CBD Product Bill Introduced

Three senators introduce legislation to allow FDA to regulate hemp-derived CBD products like other new dietary ingredients, foods, and beverages.

FDA General

ACRA McMeekin Talks Up New Inspectional Affairs Council

FDA associate commissioner for regulatory affairs Judy McMeekin updates the Food and Drug Law Institute on inspectional activity overseen by the new F...

FDA Gets HHS Grant to Expand CURE ID Platform

FDA gets a $9.2 million HHS grant to expand CURE ID for automated data collection from electronic health records and clinical disease registries.

Human Drugs

Draft Guide on Chemo-induced Nausea Drugs

Federal Register notice: FDA makes available a draft guidance entitled Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention.