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Guide: Grandfathering Product Sans Product Identifier

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Federal Register notice: FDA makes available a final guidance entitled Grandfathering Policy for Packages and Homogenous Cases of ...

ADMA Biologics FDA-483 Has 8 Observations

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FDA releases an ADMA Biologics FDA-483 with eight inspection observations.

FDA Sees No New Nuplazid Risks

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FDA says its review of deaths and adverse events associated with Acadias Nuplazid did not show any new or unexpected safety findin...

Advanced Manufacturing Technology Grants

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FDA awards five grants for improvements to continuous manufacturing of biological products.

Field Correction on Altitude-affected Balloon Pumps

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Getinge begins a field correction on about 5,223 Maquet/Getinge Cardiosave intra-aortic balloon pumps due to a potential interrupt...

FDA Disagrees with Breast Implant Safety Findings

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FDA disputes findings published in the Annals of Surgery that suggested an increased risk of certain connective tissue conditions,...

Janssen NDA for Urothelial Cancer Drug

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Janssen Pharmaceutical files an NDA seeking approval of erdafitinib for treating certain patients with locally advanced or metasta...

California Sues Abbvie Over Illegal Kickbacks

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California files a lawsut against AbbVie alleging that it gave illegal kickbacks to health care providers to prescribe Humira (ada...

FDA Lifts, Then Dashes LASIK Patients Hopes

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After a decade of stonewalling injured patients complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH l...

Docket Number Corrected on Post-approval Changes Guide

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Federal Register notice: FDA corrects an incorrect docket number appearing in a 9/11 Federal Register notice entitled Post-approva...