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FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 2/21/2020.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Info Collection for Device Corrections/Removals

Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices; Reports of Corrections and Removals 21 CFR Pa...

Federal Register

Final Rule Defines Biological Product

Federal Register final rule: FDA issues a final rule to amend its regulation that defines biological product to incorporate changes made by legislatio...

Federal Register

FDA Reclassifying Certain HIV Tests

Federal Register proposed order. FDA proposed to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests a...

Federal Register

Info Collection on Custom Device Exemption

Federal Register notice: FDA seeks comments on an information collection extension for Annual Reporting for Custom Device Exemption.

Human Drugs

FDA Releases Drug Approval Compilation Since 1985

FDA launches a new resource for external and agency researchers collecting historical information about FDAs drug approvals.

Federal Register

Device Panel to Review 5 Classifications

Federal Register notice: FDA announces a 4/23-24 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting.

Human Drugs

Guide on Drug eSubmissions Using cCTD Specs

FDA posts a revised guidance on drug application submissions that use electronic Common Technical Document specifications.

Human Drugs

Pilot Backs Blockchain for Drug Supply Security

A drug supply chain security pilot program endorses blockchain technology to meet Drug Supply Chain and Security Act requirements for the U.S. pharmac...