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Senate Bill to Restore FDA Orphan Drug Interpretation

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Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduce legislation entitled the Retaining Access and Restoring Exclusivit...

Senate Draft User Fee Bill Sets IVD Regulation

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The Senate HELP Committee releases a discussion draft of a bill that would reauthorize user fee programs for another five years an...

Travere Therapeutics NDA Accepted for Sparsentan

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FDA accepts for priority review a Travere Therapeutics NDA for sparsentan and its use in treating IgA nephropathy.

Howard Head Debarred for 5 Years

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Federal Register notice: FDA debars for five years Howard Stanley Head from importing or offering for import any drug into the U.S...

Final Guide on Investigating Out-of-spec Results

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FDA posts a final guidance entitled Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.

Avanos Recalls Cortrak 2 Enteral Access Device

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Avanos Medical recalls (Class 1) its Cortrak 2 Enteral Access System due to reports of injuries and patient deaths after nasoenter...

New Home Covid Test Gives Results for Flu, RSV too

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FDA issues an Emergency Use Authorization (EUA) for the Labcorps Covid-19+Flu+RSV Test Home Collection Kit for use with the Labcor...

Clinical Hold Lifted on Gilead HIV Therapy

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FDA removes a clinical hold on Gilead Sciences injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis.

FDA Hits Lupins Novel Labs with 13-item 483

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A March FDA inspection of Novel Laboratories (dba Lupin Somerset) leads to a 13-item FDA Form-483 that cites significant and repea...

FDA Rejects EUA for Fluvoxamine in Covid

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FDA rejects an emergency use authorization request filed by University of Minnesota Medical School infectious disease physician Da...