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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 announces the revocations of Emergency Use Authorizations issued to manufacturers of certain protecti...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion seeks approval to expanding on previous direct-to-consumer advertising research involv...[ Price : $8.95]
CDRH director Jeff Shuren says the Center has seen its work load grow substantially under the Covid-19 pandemic, and its having a ...[ Price : $8.95]
FDA adds product disposal content to a question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical P...[ Price : $8.95]
FDA updates its 2019 safety communication on Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms...