FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 1/28/2022.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Comments Extended on Device Modeling/Simulation Guide

Federal Register notice: FDA extends the comment period for a 12/23 notice on a draft guidance entitled Assessing the Credibility of Computational Mod...

Federal Register

Info Collection on FDA Communications Testing

Federal Register notice: FDA sends to OMB an information collection extension entitled Generic Clearance for Quantitative Testing for the Development ...

FDA General

House Health Subcommittee Hearing on User Fee Agreements

The House Energy and Commerce Committees Health Subcommittee announces a 2/3 user fee reauthorization hearing that will review FDA/industry agreements...

Federal Register

Device Export Foreign Approval Letters Info Collection

Federal Register notice: FDA seeks comments on an information collection extension entitled Export of Medical Devices; Foreign Letters of Approval.

Federal Register

Susceptibility Test Interpretive Criteria Updates

Federal Register notice: FDA is announcing the availability of its annual compilation of update notices related to the agencys Susceptibility Test Int...

Human Drugs

Lilly Scraps Lupus Development Program

Eli Lilly says it is discontinuing its Phase 3 development program for JAK inhibitor Olumiant (baricitinib) in adults with active systemic lupus eryth...

Human Drugs

Another Sponsor Quits Over Post-marketing Study Disagreement

Joining Incyte in withdrawing an NDA over a confirmatory study disagreement, Regeneron Pharmaceuticals and Sanofi withdraw their supplemental BLA for ...

FDA General

Is FDA Commissioner Nominee in Jeopardy?

FDA commissioner nominee Robert Califfs chances of passing a Senate vote narrow as he reportedly loses some Senate backing and the White House has bee...