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FDA updates its 2019 safety communication on Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Requesting FDA Feedback on Combination Products.[ Price : $8.95]
FDA clears an Ensemble Orthopedics 510(k) for its Ensemble CMC Implant for treating patients with early-stage osteoarthritis of th...[ Price : $8.95]
FDA approves labeling changes on Mercks Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (...[ Price : $8.95]
Federal Register notice: FDA corrects an 11/25 notice on a guidance entitled Formal Meetings Between the Food and Drug Administrat...[ Price : $8.95]
Two drug companies comment on an FDA draft guidance on developing drugs and biologics for adjuvant treatment of bladder cancer.[ Price : $8.95]
Genus asks a Maryland federal court to require FDA to withdraw its approval of Lannett Numbrino because Lannett made materially un...[ Price : $8.95]
FDA watchers speculate that former commissioner David Kessler and former principal deputy commissioner Joshua Sharfstein are top c...