FDA Related News

Human Drugs

FDA Accepts Revolution Medicines' NDA for Pancreatic Cancer Therapy

FDA accepts for review Revolution Medicines' NDA for daraxonrasib, an investigational oral RAS-targeted therapy for patients with previously treated m...

2026 Warning Letter Trends Analyzed by Attorney

Attorney Megan Robertsons analysis of 2026 FDA Warning Letters shows that CDER has been the most active Center, going after telehealth companies selli...

Human Drugs

4 Observations in Behring German Facility Inspection

FDA releases the form FDA-483 issued following a 2026 inspection at the CSL Behring biological drug manufacturing facility in Marburg, Hessia, Germany...

Human Drugs

FDA Cites Cliantha Research on Data Integrity, Quality Unit

FDA investigators cite contract research organization Cliantha Research over data integrity, documentation and clinical research deficiencies followin...

Medical Devices

Petition Urges FDA to Create Pathway for Brain-Computer Interfaces

A citizen petition urges FDA to establish a regulatory framework for implantable brain-computer interfaces designed to expand human sensory perception...

FDA General

FDA May Go Months Without Senate-Confirmed Commissioner: Analysis

An analysis by PharmaVoice says FDA could remain without a Senate-confirmed commissioner for months as political and procedural hurdles complicate eff...

Human Drugs

Diamantas Touts FDA Moves to Boost U.S. Jobs

FDA acting commissioner Kyle Diamantas uses a Fox News editorial to tout agency steps he says are providing new jobs for American workers and protecti...

Medical Devices

FDA Selects Dexcom as First Participant in Digital Health Pilot with CMS

FDA names Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot.

Marketing

FDA Plan Would Fundamentally Reshape Drug Ads

Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within the content of direct-to-consumer radio and TV ads w...

Medical Devices

FDA, Industry Have MDUFA 6 Agreement in Principle

Attorney Jake Leys says MDUFA 6 reauthorization has moved from negotiations into writing the commitment letter that spells out all that FDA and the me...