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FDA approves a TaiwanJ Pharmaceuticals IND application for a Phase 2 clinical trial in patients with autoimmune hepatitis intolera...[ Price : $8.95]
FDA clears a Roxwood Medical 510(k) for the CenterCross Catheter and its use in the coronary and peripheral vasculature.[ Price : $8.95]
FDA grants accelerated approval for an AstraZeneca NDA for Lynparza (olaparib) and its use in treating women with advanced ovarian...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America says it is highly concerned about FDAs plans to focus on risk evaluation and ...[ Price : $8.95]
FDA asks Herbalife to stop running a broadcast advertisement and YouTube video that mischaracterizes the agencys regulatory role w...[ Price : $8.95]
Federal Register Notice: FDA plans a public conference 3/18-19/15 on serious drug-induced livery injuries.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a certificatio...[ Price : $8.95]
CDRH posts a draft guidance on Transfer of a Premarket Notification (510(k) Clearance Questions and Answers.