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CDERs Office of Generic Drugs launches a new pilot program to offer meeting opportunities to generic drug applicants who intend to...[ Price : $8.95]
FDA Webview editor Jim Dickinson discovers high-level corruption equivalent to the 1989 Generic Drug Scandal in Jeff Shurens CDRH,...[ Price : $8.95]
FDA approves a Novo Nordisk NDA for Rivfloza (nedosiran) injection, a once-monthly subcutaneous ribonucleic acid interference ther...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Human Prescription Drug and Biological Products Labeling f...[ Price : $8.95]
FDA clears an Anumana 510(k) clearance for ECG-AI LEF, an artificial intelligence-powered medical device to detect low ejection fr...[ Price : $8.95]
Novartis says it will seek accelerated approval next year for its IgA nephropathy drug iptacopan after announcing positive top-lin...[ Price : $8.95]
Federal Register notice: FDA announces the opportunity for a limited number of development programs to participate in the Support ...[ Price : $8.95]
The U.S. government and agencies like FDA headed into the weekend as the ongoing Congressional budgetary impasse was on course to ...