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Radiology Display Device Submission Guidance

[ Price : $8.95]

FDA publishes a guidance on preparing 510(k) submissions for display devices intended for diagnostic radiology.

Medical Device Data Systems Guidance

[ Price : $8.95]

FDA publishes a revised guidance on medical device data systems to conform with the 21st Century Cures Act.

Animal Drug Application Actions Posted

[ Price : $8.95]

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applica...

Meeting on Animal Generic Drug User Fees

[ Price : $8.95]

Federal Register notice: FDA announces a 10/26 public meeting entitled Animal Generic Drug User Fee Act.

FDA in New AMP Heart Failure Program

[ Price : $8.95]

FDA joins with the NIH and other organizations in a new Accelerating Medicines Partnership program on heart failure.

Sarepta Submits BLA for Duchenne Gene Therapy

[ Price : $8.95]

Sarepta Therapeutics files a BLA seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patient...

Dupixent Gains OK for Prurigo Nodularis

[ Price : $8.95]

FDA approves Regeneron Pharmaceuticals Dupixent (dupilumab) for treating adult patients with prurigo nodularis. a chronic, inflamm...

Comments on COA Guidance

[ Price : $8.95]

Four stakeholders suggest ways FDA could improve a draft guidance on fit-for-use clinical outcome assessments.

Final Guide on Revised Covid Test Policy

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Policy for Coronavirus Disease 2019 Tests During the Publi...

OTC Monograph eSubmission Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Providing Over-the-Counter Monograph Submissions in Electro...