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Federal Register notice: FDA issues an order permanently debarring Barry J. Cadden after a conviction in his role as an owner and ...[ Price : $8.95]
FDA approves a Rhythm Pharmaceutical NDA for Imcivree (setmelanotide) for chronic weight management in patients six years and olde...[ Price : $8.95]
FDA launches the Innovative Science and Technology Approaches for New Drugs pilot program for novel drug development tool develope...[ Price : $8.95]
Moderna submits an emergency use authorization for its Covid-19 vaccine mRNA-1273 based on updated efficacy data showing 94.1% vac...[ Price : $8.95]
FDA approves a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bo...[ Price : $8.95]
Federal Register notice: FDA posts a final guidance on its drug development tool qualification process.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Formal Meetings Between FDA and ANDA Applicants of Complex ...[ Price : $8.95]
FDA updates a CDRH Covid-19 guidance on notifying the agency of medical device discontinuance or shortages.