FDA Related News

FDA General

FDA WEBVIEW CLOSED JULY 4TH WEEK

In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 11.

Federal Register

FDA Seeks Consumer Reps for Advisory Committees

Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting consumer representative...

Human Drugs

FDA Copiktra Warning About Higher Risk of Death

FDA says clinical trial results show an increased risk of death and serious side effects associated with Secura Bios cancer drug Copiktra.

Biologics

Add Omicron BA.4/5 Component to Boosters: FDA

FDA tells Covid-19 vaccine manufacturers seeking to update their vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike ...

Comments on OPDP Research Proposal

Three drug company stakeholders suggest changes to research proposed by the CDER Office of Prescription Drug Promotion.

FDA General

Califf Adds 2 Senior Officials to Leadership Team

FDA commissioner Robert Califf taps former Johns Hopkins School of Medicine professor Namandj N. Bumpus as the agencys new chief scientist, and former...

Medical Devices

Sentators Urge FDA to Allow OTC Hearing Aids

Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) urge FDA to finalize a proposed rule on making certain hearing aids available over the coun...

Biologics

FDA Review Extended on Provention Bio BLA

FDA extends by three months the review of a Provention Bio BLA for teplizumab, indicated for delaying progression to Stage 3 clinical Type 1 diabetes ...

Federal Register

Optical Melanoma Detection Device Reclassified

Federal Register notice: FDA proposes to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from Clas...

Human Drugs

Pfizer Submits Paxlovid NDA

Pfizer submits an NDA to FDA for Paxlovid to treat Covid-19 patients at high risk for progression to serious illness.