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Draft Guide on Device Maker Computer Software Assurance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Computer Software Assurance for Production and Quality Syst...

Right to Try Annual Summary Reporting Rule

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FDA publishes a final rule setting a new deadline for the annual summary report required under the Right to Try Law.

ISCT Criticizes Ruling in Cell, Gene Therapy Case

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The International Society for Cell & Gene Therapy says a federal court decision that FDA cannot regulate cell therapy products as ...

New OND Research Web Page

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FDA launches a new Web page to highlight CDER Office of New Drugs regulatory science research activities.

FDA Withdraws Merck NDA for Vioxx

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Federal Register notice: FDA withdraws approval of a Merck NDA for arthritis drug Vioxx (rofecoxib).

FDA Report on Generic Drug Approval Cost Savings

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An FDA report says generic drug approvals in 2018-2020 led to billions of dollars in savings.

FDA in Pistoia Alliance Working Group

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CDER representatives will participate in an In Vitro Pharmacology working group being assembled by Pistoia Alliance.

User Fee Reauthorization Talks Continue

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Congressional negotiations on FDA user fee reauthorization are continuing, with some major changes in play, according to Politico....

CDER Planning Guidance on Clinical Trial Modernization

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CDER Office of Compliance director Don Ashley tells a regulatory conference that the Center is planning a guidance document on the...

FDA Denies Petition on Colonoscopy Preparation

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FDA denies a Braintree citizen petition that asked it not to approve a tablet-based or tablet-containing colonoscopy preparation u...