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FDA Seeks Non-voting Members for Device Advisory Panels

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Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of nonvoting in...

FDA Safety Alert on Endovascular Graft Systems Leaks

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FDA alerts vascular surgeons about Type IIIa and IIIb endoleaks with the use of endovascular graft systems for aneurysm repair pro...

Lilly Gains Approval for Verzenio for Breast Cancer

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FDA approves an Eli Lilly NDA for Verzenio (abemaciclib) for treating adult patients who have hormone receptor-positive, human epi...

FDA Clears Expanding Orthopedics Cage

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FDA clears an Expanding Orthopedics 510(k) for the FLXfit 15 3D Expandable Cage System for restoring lumbar lordosis while control...

FDA Extending REMS to IR Opioids

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FDA commissioner Scott Gottlieb outlines additional steps the agency is taking to try to cut overall exposure to opioids.

Toxicity Testing, Labeling Guidance Out

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FDA publishes a draft guidance on reproductive toxicity assessments for anti-cancer drugs.

ANDA Deficiency Communication MAPP

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CDER issues a MAPP for ANDA filing reviewers on the procedure for communicating with applicants about submissions that contain min...

New Search Tool for FDA Adverse Events Database

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FDA launches a new search tool to improve access to data on drug and biologic adverse events through its Adverse Event Reporting S...

More Steps to Help Compounders Register for Outsourcing

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FDA releases two documents and plans more steps to help drug compounders register as outsourcing facilities.

Court Rejects Medtronic Fraud on FDA Case

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Hyman, Phelps attorneys say that a California federal court rejected a whistleblower suit against Medtronic over fraud-on-FDA and ...