FDA Related News

Human Drugs

No More Opioid Enriched Enrollment Studies: Califf

During a Senate Appropriations hearing, FDA commissioner Robert Califf tells lawmakers that the agency is advising against enriched enrollment studies...

Biologics

BLA Accepted for Subcutaneous Opdivo

FDA accepts for review a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously approved adult solid tumo...

Medical Devices

FDA Defines Device Remanufacturing

FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.

FDA General

FDA Leaders Financial Ties to Drug Industry Probed

A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.

Biologics

Exocel Bio Selling Unapproved Exosomes: FDA

FDA says Exocel Bio in San Diego is marketing unapproved exosome products.

Human Drugs

ORA Reorgs Impact on Drug Inspections: Cavazzoni

CDER director Patrizia Cavazzoni provides an update on the reorganization of FDAs Office of Regulatory Affairs (ORA) regarding inspection activities, ...

Human Drugs

Breakthrough Status for Myotonic Dystrophy Therapy

FDA grants Avidity Biosciences a breakthrough therapy designation for delpacibart etedesiran and its use in treating myotonic dystrophy Type 1.

Medical Devices

FDA on Ongoing Getinge Device Concerns

FDA reminds healthcare providers and facilities about the agencys continuing safety and quality concerns with some Getinge/Maquet cardiovascular medic...

FDA, EPA, USDA Biotechnology Plan

FDA says it has worked with EPA and USDA to develop a biotechnology regulatory reform program as required by a presidential Executive Order.

Human Drugs

FDA Grants, Denies Kaiser 2009 REMS Petition

FDA grants in part and denies in part a 14-year-old Kaiser Permanente petition on the development, implementation, and evaluation of REMS.