FDA Related News

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...

Human Drugs

FDA Approves GSK's Jideytro for ROS1-Positive Lung Cancer

FDA approves GSK's Jideytro (zidesamtinib) for certain adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

FDA General

FDA Reform Requires a Whole-of-System Strategy: Editorial

A Cureus Journal of Medical Science open-source editorial calls for a rebuilding of the U.S. scientific infrastructure as the only way to successfully...

FDA General

House Passes FDA Modernization Act 3.0 for Reducing Animal Testing

The U.S. House of Representatives passes the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to accelerate the adopti...

Marketing

FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus prevention product Beyfortu...

Novo Nordisk Sues Lilly Over GLP-1 Ads

Novo Nordisk sues Lilly in New Jersey federal court over what the company says is a misleading national ad campaign that compares the two companies GL...

Human Drugs

CGMP Issues at Indias Shimoga Chemicals

FDA warns Indias Shimoga Chemicals about CGMP deviations in its production of active pharmaceutical ingredients.