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Fake Weight Loss Drugs Concern Califf

[ Price : $8.95]

FDA commissioner Robert Califf expresses concern about fake and compounded weight-loss drugs and the disparity in the availability...

FDA Clears Nevro Sacroiliac Joint Fusion Device

[ Price : $8.95]

FDA clears a Nevro 510(k) for its Nevro1 sacroiliac joint fusion device for treating chronic SI joint pain.

Medtronic Recalls Cerebrospinal Fluid Drain

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Medtronic Neurology recalls its Duet External Drainage and Monitoring System, which is used to drain cerebrospinal fluid (CSF) to ...

U.S. Generally Fastest in New Drug Launches

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An HHS-funded RAND study finds that many new drugs are available in the U.S. before launching in other countries.

Baxter Debarment Reduced by 3 Years

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Federal Register notice: FDA issues an order to reduce a five-year debarment against former Indivior global medical director Timot...

Supreme Court Could Hit FDA Regulation: FDLI

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A detailed FDLI analysis looks at how expected Supreme Court changes to the Chevron federal agency deference principle will likely...

Priority Review Granted for Galactosemia NDA

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FDA accepts for priority review an Applied Therapeutics NDA for AT-007 (govorestat) for treating classic Galactosemia.

Marks Sees Breakout Year in Gene Therapy Approvals

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CBER director Peter Marks says he expects 2024 to be a big year for gene therapy approvals as several Center initiatives take hold...

Questions on Topical Ophthalmic Draft Guide

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Four stakeholders update comments on the latest version of an FDA draft guidance on topical ophthalmic products.

Significant CGMP Violations at Amman Pharmaceutical

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FDA warns Amman, Jordan-based Amman Pharmaceutical Industries about CGMP violations in its production of drugs as a contract manuf...