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Make FDA an Independent Agency: Politico Column

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University of California resident surgeon Nisarg Patel calls on Congress to make FDA an independent agency to help it weather poli...

Novartis Approves Cosentyx for Axial Spondyloarthritis

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FDA approves Novartis Cosentyx (secukinumab) for treating active non-radiographic axial spondyloarthritis.

Virtual Meeting on Device Patient-Reported Outcomes

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FDA announces a 9/30 virtual public meeting entitled Patient-Reported Outcomes and Medical Device Investigations: From Conception ...

Klarity Medical Inspection Violations

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FDA warns Klarity Medical Products that it is selling an unapproved medical device and also has multiple Quality System and Medica...

ANDA Withdrawal Notice Corrected

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Federal Register notice: FDA corrects a 3/9 notice that announced the withdrawal of approval of 16 ANDAs abbreviated from multiple...

4 Unapproved Homeopathic Injectable Manufacturers Warned

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FDA warns four manufacturers of unapproved injectable drugs labeled as homeopathic.

CGMP Deviations at Fenwal International

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FDA warns Fenwal International about CGMP deviations in manufacturing the firms blood-pack units with and without in-line leukored...

Appeals Court Backs Rejection of Rule on Drug Price Ads

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The DC Appeals Court affirms the DC federal courts rejection of an HHS rule requiring drug companies to include the wholesale acqu...

FDA Approves Jazz Zepzelca for Some Lung Cancers

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FDA says it approved Jazz Pharmas Zepzelca for treating some small cell lung cancer cases.

Lilly BLA for Insulin Lispro Approved

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FDA approves an Eli Lilly BLA for Lyumjev (insulin lispro-aabc) injection, a new rapid-acting insulin indicated to improve glycemi...