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HRA Pharma files an NDA for an Rx-to-OTC switch for the companys Opill (norgestrel .075 mg), a progestin-only daily birth control ...[ Price : $8.95]
After a 22-year career at FDA, CDER Office of Generic Drugs Division of Legal and Regulatory Support deputy director Martin H. Shi...[ Price : $8.95]
The National Hemophilia Foundation says FDA should require a REMS for two investigational gene therapies being reviewed as hemophi...[ Price : $8.95]
FDA says state-licensed pharmacists may prescribe Paxlovid but not Lagevrio.[ Price : $8.95]
FDA gives 510(k) clearance to a VideaHealth algorithm that can help dentists identify dental caries on patient X-rays.[ Price : $8.95]
Two Covington & Burley attorneys review the history of court preemption decisions involving over-the-counter drug monograph produc...[ Price : $8.95]
CDER Office of Pharmaceutical Quality deputy director Mahesh Ramanadham outlines advantages found in an agency self-audit comparin...[ Price : $8.95]
Federal Register notice: FDA withdraws the approval of Xellia Pharmaceuticals ANDA for bacitracin for injection after the company ...