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FDA Wins Restraining Order Against Xephyr

[ Price : $8.95]

An Oklahoma federal court grants a temporary restraining order against Xephyr LLC, doing business as N-Ergetics, and three company...

FDA Alert on False Negatives on Abbott Covid Test

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FDA issues an alert about preliminary data from New York University researchers suggesting potential inaccurate results (false neg...

Info Collection Revision on Administrative Procedures

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Federal Register notice: FDA sends to OMB an information collection revision for General Administrative Practice and Procedures.

Guide on Covid-19 Test Policies

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Federal Register notice: FDA makes available a final guidance entitled Policy for Coronavirus Disease-2019 Tests During the Public...

House Bill Includes New FDA Responsibilities

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Alliance for a Stronger FDA deputy executive director Steven Grossman summarizes five key FDA provisions in a White House-opposed ...

Deciphera NDA for Gastrointestinal Tumors OKd

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FDA approves a Deciphera Pharmaceuticals NDA for Qinlock (ripretinib) tablets as a fourth-line treatment for advanced gastrointest...

FDA Rejects Blueprint Medicines NDA for Avapritinib

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FDA issues Blueprint Medicines a complete response letter for its NDA for avapritinib, indicated for treating adults with unresect...

FDA Denies Drug Compounding MOU Petition

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FDA denies a petition seeking to delay agency development of a memorandum of understanding with states on regulating drug compound...

Info Collection Extension for Electronic Programs

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Federal Register notice: FDA sends to OMB an information collection extension entitled Electronic Products.

Info Collection Revision on Drug Compounding

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Federal Register notice: FDA sends to OMB an information collection revision for Human Drug Compounding Under Sections 503A and 50...