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Regulatory Review Lags Yield Fewer Drugs in Development

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University researchers say delays in FDA new drug regulatory reviews lead to fewer new drugs being in development.

28 Drugs Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that 28 drug products listed in the notice were not withdrawn from sale for safety or effe...

Complete Response Letter for Zosanos Qtrypta

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FDA issues a complete response letter for Zosano Pharmas Qtrypta 505(b)(2) NDA.

Guide on Postmarketing Requirements/Commitments

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Federal Register notice: FDA makes available a draft guidance entitled Annual Status Report Information and Other Submissions for ...

Lilly Retains Outside Consultant to Help After Inspections

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Eli Lilly says it has retained an outside consultant to conduct a comprehensive independent review of systems at its Branchburg, N...

Fast Track Designation for TG Therapeutics Cancer Drug

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FDA grants fast track designation for TG Therapeutics ublituximab and umbralisib to treat chronic lymphocytic leukemia.

FDA Prevagen Concerns Aired

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A Wired investigation details how Quincy Bioscience has made millions from Prevagen sales despite many FDA questions and consumer ...

Tyber Medical Foot/Ankle Plating Systems Cleared

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FDA clears a Tyber Medical 501(k) for its new line of foot and ankle plating systems.

FDA Wants More Info on Helius Technologies PoNS

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FDA asks Helius Medical Technologies for more information to support its request for de novo clearance of its portable neuromodula...

Feds Settle with Purdue Pharma and Sackler Family

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The Justice Department announces a global settlement with Purdue Pharma and the Sackler family worth more than $8.3 billion.