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Multiple Violations at Vitang Technology

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FDA warns Tustin, CA-based Vitang Technology that its UniSmile Dental Aligner is misbranded and adulterated and thus is being sold...

Arcellx CAR-T Therapy on Clinical Hold

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FDA issues a clinical hold on Arcellxs CART-ddBCMA for treating patients with relapsed or refractory multiple myeloma, after a rec...

Panel to Vote on 2 Hypertension Devices

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Federal Register notice: FDA announces an 8/22-23 advisory committee meeting to review a ReCor PMA and a Medtronic PMA for their d...

Professor Calls for Alzheimers Drugs REMS

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University of Pennsylvania medical school professor Jason Karlawish makes the case for FDA to require a detailed REMS for new Alzh...

FDA Grants, Denies BI Spiriva Petition

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FDA explains its reasoning for granting in part and denying in part a Boehringer Ingelheim 2012 petition concerning its Spiriva Ha...

New Areas of ICH Harmonization

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The International Council for Harmonization Assembly approves the addition of three new topics for harmonization.

FDA Extends Neffy NDA Review

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FDA has extended by three months an ARS Pharmaceuticals NDA for neffy (intranasal epinephrine) for treating allergic reactions, in...

Surmodics Drug-Coated Balloon Approved

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FDA approves Surmodics SurVeil drug-coated balloon and its use in percutaneous transluminal angioplasty.

FDA Reports on State of Pharmaceutical Quality

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The CDER Office of Pharmaceutical Quality FY 2022 report on pharmaceutical quality shows a significant increase in drug site surve...

Legislation Introduced on Drug Supplies, Shortages

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Senators Gary Peters (D-MI) and Joni Ernst (R-IA) introduce bipartisan legislation to ensure the government is better prepared to ...