FDA Related News

Senate HELP Committee: 15 Ways to Reform FDA

The Senate HELP Committee offers an initial 15 recommendations for reforming FDA as part of what it says will be a collaborative, bipartisan process.

Human Drugs

FDA DTC Crackdown Reshapes Industry Creative Approach

Drug advertising consultant Bob Ehrlich says the recent wave of FDA enforcement letters on drug promotion activities is reshaping how pharmaceutical c...

Medical Devices

FDA Shifts to Risk-Based Device Inspections under QMSR

As part of FDAs recent implementation of the Quality Management System Regulation, a new risk-based inspection model is set to change medical device o...

Human Drugs

PTC Yanks Translarna NDA After FDA Signals Data Shortfall

PTC Therapeutics withdraws its NDA resubmission for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy, following feedback f...

Human Drugs

Cotton Urges FDA Probe Into Chinese APIs for GLP-1 Drugs

Sen. Tom Cotton (R-AR) urges FDA to investigate whether illegal or unregulated Chinese-sourced active pharmaceutical ingredients have entered the U.S....

Human Drugs

FDA Rejects Commissioner's Voucher Drug

FDA issues Disc Medicine a complete response letter for its experimental therapy bitopertin, indicated for treating erythropoietic protoporphyria.

Human Drugs

Zydus India Plant Cited After FDA Inspection

FDA cites Zydus Lifesciences sterile drug manufacturing facility in Vadodara, India, for significant quality control and aseptic processing deficienci...

Human Drugs

FDA Should Move More Drugs OTC: Opinion

Singer further suggests that Congress could explore forms of international drug reciprocity, allowing Americans to purchase certain drugs over the cou...

Human Drugs

Common Violations in Recent DTC Letters from FDA

A law firm examines FDAs renewed scrutiny of direct-to-consumer television advertising after issuing seven untitled letters so far in 2026.

Medical Devices

Medline Class 1 Recall on Malfunctioning Beds

Medline recalls (Class 1 device correction) certain Medline homecare beds as a Class I recall, warning that continued use without updated instructions...