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Azurity Pharma Recalls 1 Lot of Zenzedi

[ Price : $8.95]

Azurity Pharmaceuticals recalls one lot of narcolepsy drug Zenzedi CII (dextroamphetamine sulfate tablets, USP) 30 mg after a repo...

Merck Keytruda Data Positive in Bladder Cancer

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Merck says data from its Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial evaluating Keytruda (pembrolizumab) are favorable for the ...

De Novo OK for Google Phone Thermometer

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FDA grants Google a de novo marketing authorization for its new body temperature app on its latest Pixel 8 Pro smart phone.

Postmarketing Drug Surveillance Best Practices

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FDA releases a document entitled Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biologica...

FDA Should Identify AI Legislative Changes: GAO

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A new GAO reports recommends that FDA identify and document specific changes to its statutory authorities that would enable it to ...

ICH Guide on Analytical Procedure Development

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The International Council for Harmonization releases a guidance entitled Q14 Guideline on Analytical Procedure Development.

Remote Regulatory Assessments Draft Guide

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FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments (RRA) Questions and Answers.

Vaccines/Biologics Advisory Committee Renewal

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Federal Register notice: FDA announces the renewal of its Vaccines and Related Biological Products Advisory Committee for an addit...

FDA Delays Review Action on Liquidia NDA

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FDA tells Liquidia Corp. that its earlier user fee review action target date of 1/24 will be missed on the companys NDA for Yutrep...

FDA Featured in 2024 Top-of-Mind Issues Report

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A Sheppard Mullin report describes several FDA issues that life sciences companies can expect to face in 2024.