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Federal Register

Guide on Small Business Determination

Federal Register notice: FDA makes available a draft guidance on how to determine the number of employees for purposes of a small business definition....

FDA General

Amazon Hires Former FDA Chief Information Officer

Amazon hires former FDA chief health information officer Taha Kass-Hout, a sign that the online retailing behemoth may be challenging Google and its X...

Federal Register

Public Workshop on Pathways to Global Unity

Federal Register notice: FDA announces a 6/11-12 public workshop on Pathways to Global Unity.

Human Drugs

House Again Takes Up Right-to-Try; 4 Ex-FDA Heads Oppose

Four former FDA commissioners issue a brief joint statement opposing a right-to-try bill as House Republicans prepare to advance the measure through t...

Human Drugs

FDA Posts 1st Clinical Study Report in Transparency Pilot

A new FDA drug approval transparency pilot program releases the first Clinical Study Report that provides more background on why the agency recently a...

Human Drugs

FDA Accepts pSivida NDA for Durasert

FDA accepts a pSivida Corp. NDA for Durasert three-year treatment for posterior segment uveitis.

Medical Devices

FDA Clears Cook Medical Laser Endomicroscopy

FDA clears a Cook Medical 510(k) for the Cellvizio Confocal Laser Endomicroscopy System and the Confocal Miniprobes.

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 3/16/2018.

Human Drugs

Tetra Discovery Gains IND OK for Fragile X Study

FDA approves a Tetra Discovery Partners IND for BPN14770, a novel, selective small molecule inhibitor of the phosphodiesterase type-4D enzyme.

Federal Register

Arthritis Drugs Panel to Review Eli Lilly NDA

ederal Register notice: FDA announces a 4/23 Arthritis Advisory Committee meeting that will review an Eli Lilly NDA for baricitinib tablets.