FDA Related News

Medical Devices

SunMed Manual Resuscitators Recalled

SunMed Holdings recalls its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral filter.

Marketing

Sen. Durbin Calls for Crackdown on DTC Telehealth

Senator Dick Durbin (D-IL) calls for a crackdown on pharmaceutical companies growing use of direct-to-consumer telehealth platforms due to concerns ab...

Human Drugs

ICH Guide on Including Pregnant Women in Trials

FDA posts an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.

Human Drugs

FDA Rejects Genentechs Bid to Expand Columvi Use

FDA rejects Genentechs bid to broaden the use of its lymphoma drug Columvi.

Human Drugs

Panel Votes Down Rexulti for PTSD

FDAs Psychopharmacologic Drugs Advisory Committee votes against approving an Otsuka Pharma NDA for Rexulti (brexpiprazole) when used in combination wi...

Biologics

FDA Mulls Pulling Sareptas Gene Therapy

An HHS official says FDA is taking a hard look at pulling from the market Sarepta Therapeutics gene therapy Elevidys (delandistrogene moxeparvov...

CDER Losing Staff In Droves: Report

An online post details a significant number of resignations from CDER in the first six months of this year.

Human Drugs

Alert on B.Braun Microbore Extension Sets

FDA issues an alert saying B. Braun Medical has notified customers recommending that certain microbore extension sets be removed from the market becau...

Human Drugs

J&Js Bladder Cancer NDA Gets Priority Review

FDA grants priority review to Johnson & Johnsons NDA for TAR-200 for treating patients with Bacillus Calmette-Gurin-unresponsive high-risk non-muscle ...

Human Drugs

pCR May Not be Valid Rectal Cancer Endpoint: Study

A Tulane University researcher says FDAs use of pathologic complete response as a surrogate endpoint for rectal cancer treatments is not supported by ...