FDA Related News

Federal Register

FDA Debars Clinical Investigator

Federal Register notice: FDA permanently debars Yvelice Villaman-Bencosme from providing services in any capacity to a person that has an approved or ...

Federal Register

FDA Revokes 5 Covid Test EUAs

Federal Register notice: FDA is revoking the emergency use authorizations on five no-longer-marketed Covid-19 tests.

Human Drugs

Pazdur et al Weigh Challenges with PI3K Inhibitors

Writing in an online Lancet Oncology article, FDA officials outline challenges with current PI3K inhibitors that have the agency reconsidering how the...

Diversity Plans Needed Before Phase 3: Law Firm

A Hogan Lovells analysis of FDAs recent guidance on clinical trial diversity plans says such plans should be an important part of drug and device deve...

Human Drugs

Nektar, BMS Nix Opdivo/Bempegaldesleukin Trials

Nektar Therapeutics and Bristol Myers Squibb end their clinical development program for bempegaldesleukin in combination with Opdivo (nivolumab) for t...

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 4/15/2022.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Medical Devices

FDA Clears SonoScape Video Endoscopy Device

FDA clears a SonoScape 510(k) for its flagship video endoscopy system HD-550 for gastrointestinal diagnosis.

Federal Register

Info Collection on Quick Turnaround Surveys

Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for Quick Turnaround Testing of Communication...

Federal Register

Guide on Bioavailability Studies for Drug Submissions

Federal Register notice: FDA makes available a final guidance entitled Bioavailability Studies Submitted in NDAs or INDs General Considerations.