FDA Related News

Federal Register

CBER Safety Report Specifications Updated

Federal Register notice: CBER makes available version 2.2 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports...

FDA General

Ex-FDAer Laughren Joins BetterLife Pharma

Retired FDA psychiatry products director Thomas Laughren joines BetterLife Pharma as a regulatory advisor.

Human Drugs

BMS Reports Positive Opdivo Results in CheckMate-648 Trial

Bristol Myers Squibb announces positive topline results from the CheckMate-648 Phase 3 Opdivo trial in some esophageal cancers.

Biologics

Gilead Gets Full Approval for Breast Cancer Drug

FDA grants Gilead Sciences full approval for Trodelvy (sacituzumab govitecan-hziy) for certain adult patients with unresectable locally advanced or me...

Biologics

FDA Posts Inspection Form From Emergent Bio

FDA posts a five-observation Form FDA-483 from a 4/2020 inspection at troubled contract manufacturer Emergent Biosolutions Baltimore manufacturing fac...

Biologics

Fiscal Year Biological Product Deviation Report Summary

CBER publishes its annual fiscal year summary of biological product and HCT/P deviation reports.

Allure Imports Selling Unapproved, Misbranded Covid-19 Drugs: FDA

FDA warns Allure Imports that it is marketing unapproved and misbranded drugs for use in humans or animals for Covid-19 indications.

Human Drugs

NIA Researchers Look to Repurpose Drugs to Help Dementia

National Institute on Aging researchers say they are evaluating whether drugs FDA approved for other indications could be repurposed to be used agains...

Medical Devices

Court Rejects Res Ipsa in Breast Implant Case: Attorney

Attorney Andrew Tauber says a New Jersey federal court reiterated that plaintiffs in medical device manufacturing defect cases cannot infer a defect s...