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Ardelyx Gets Panel Review on Tenapanor Appeal

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CDERs Office of New Drugs says it will convene its Cardiovascular and Renal Drug Advisory Committee to hear an appeal from Ardelyx...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 4/22/2022.

Guide on Nanomaterial in Drugs/Biologics

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Federal Register notice: FDA makes available a final guidance entitled Drug Products, Including Biological Products, That Contain ...

Guidance on N-Acetyl-L-Cysteine Policy

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Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine.

Covid-19 Vaccine Guidance Update

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Federal Register notice: FDA makes available an updated guidance document entitled Emergency Use Authorization for Vaccines to Pre...

Guide on 510(k) Refuse to Accept Policy

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FDA posts a final guidance entitled Refuse to Accept Policy for 510(k)s that outlines the procedures and criteria the agency inten...

Biogen Pulls European Submission on Alzheimers Drug

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Biogen withdraws a European marketing authorization application for its troubled Alzheimers drug aducanumab.

Revance BLA Resubmission Accepted for Review

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FDA accepts for review a Revance Therapeutics BLA resubmission for DaxibotulinumtoxinA for Injection, indicated for treating moder...

FDA Nixes 6 Outdated Compliance Policy Guides

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Federal Register notice: FDA withdraws six compliance policy guides because they contain duplicative information or they no longer...

Comments Sought on Electronic Drug Quality Data Submissions

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FDA seeks comments from the pharmaceutical industry on its project to identify and prioritize pharmaceutical quality and chemistry...