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FDA Webview Closed on Juneteenth (6/19)

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FDA Webview closes and will not be publishing on 6/19 in recognition of the U.S. federal holiday, Juneteenth.

FDA Warns on Transderm Scop Heat Complications

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FDA warns that Baxter Healthcares antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature a...

DTC Ads Kennedys Next Target?

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Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope would drive drug companies aw...

FDA Approves Gileads Yeztugo for HIV Prevention

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FDA approves Gileads Yeztugo as the only HIV pre-exposure prophylaxis twice-yearly option.

GDUFA Post-Warning Letter Meeting Guidance

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FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to ...

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.