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Open Bipartisan Probe of RFK Vaccine Plans: Pallone

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House Energy and Commerce Committee ranking Democrat Frank Pallone calls for a bipartisan committee investigation of HHS secretary...

CBERs Prasad Named Chief Medical/Scientific Officer

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CBER director Vinay Prasad has been appointed as FDAs chief medical and scientific officer, a new combination role for commissione...

Commissioners National Priority Voucher Program

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FDA launches the Commissioners National Priority Vouchers to speed drug reviews for companies with products that are aligned with ...

Aldeyra Files NDA Resubmission for Dry Eye Drug

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Aldeyra Therapeutics resubmits an NDA for reproxalap to treat the signs and symptoms of dry eye disease.

Zhejiang Huahai Pharmaceutical CGMP Issues

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FDA warns Chinas Zhejiang Huahai Pharmaceutical Co. about CGMP violations in its production of finished drugs.

OIG Hit FDA Accelerated Approvals

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The latest semiannual report issued by the HHS Office of Inspector General raises questions about specific FDA accelerated drug ap...

FDA Allows Companies to Skip Import Bans: Report

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A ProPublica investigative report details how a secret small group of FDA officials has approved exemptions for products from over...

Multiple Violations at Reset Technology Corp.

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FDA warns Irving, TX-based Reset Technology Corp. about Quality System and other violations in its production of two dental device...

Elevidys Shipping Nixed After 2nd Liver‑Failure Death

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Sarepta Therapeutics halts shipments of its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to nonR...

CGMP Issues at Indias Kenil Healthcare

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FDA warns Indias Kenil Private Healthcare about CGMP violations in its production of finished drugs.