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Notice Corrected on Flowtuss NDA Withdrawal

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Federal Register notice: FDA corrects a 12/18 notice that announced the withdrawal of a Chartwell RX Sciences NDA for Flowtuss.

Guide on Safety Reporting Standards

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Federal Register notice: FDA makes available a draft guidance entitled E2D(R1) Post-Approval Safety Data: Definitions and Standard...

Damning Report on Alzheimer Drug Tests: Article

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A Science investigative report looks at issues found by FDA in a laboratory analysis of results from trials of Cassavas potential ...

Cassidy Wants Test Regulation Ideas

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Republican Sen. Bill Cassidy asks interested parties to submit their ideas for congressional action to reform the regulation of cl...

FDA Approves Madrigal Fatty Liver Drug

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FDA approves a Madrigal Pharmaceuticals NDA for Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatoh...

Post-Approval Safety Data Reporting Guide

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FDA publishes a draft ICH guidance on post-marketing individual case study reporting.

Advisors to Weigh Imetelstat Benefits, Risks

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FDA medical reviewers ask the Oncology Drug Advisory Committee to weigh the benefits of the benefits and serious risks of Gerons i...

ODAC Looking at Increased Deaths in 2 Drugs

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FDA asks the Oncologic Drugs Advisory Committee to evaluate the higher risk of early deaths in trials supporting sBLAs for Celgene...

Need to Creatively Regulate Software as Device: Atty.

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Mintz attorney Benjamin Zegarelli says FDA needs to develop creative ways to regulate software as a medical device while it waits ...

FDA Budgets to Expand Foreign Footprint

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FDA associate commissioner for global policy and strategy Mark Abdoo says the agency is requesting funds to begin expanding its fo...