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MAPP on SGEs Representing Sponsors Before FDA

[ Price : $8.95]

CDER issues a Manual of Policies and Procedures for instances in which a CDER special government employee wants to represent a spo...

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...

Texas Longhorn RX Producing Illegal Drugs: FDA

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FDA warns Texas Longhorn RXs Talon Pharmacy of Boerne, Boerne Texas, about selling adulterated compounded drug products.

$2 Million FDA Grant to Marker Therapeutics

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FDA grants $2 million to Marker Therapeutics to support the treatment arm in a Phase 2 trial of its T-cell candidate to treat pati...

Preserve Access to Compounded Hormones: APC

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The Alliance for Pharmacy Compounding calls on FDA to reject recommendations in a National Academies report and instead maintain p...

Draft Guide on Device Maker Computer Software Assurance

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Federal Register notice: FDA makes available a draft guidance entitled Computer Software Assurance for Production and Quality Syst...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