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Suggestions for ICH Good Clinical Practice Guideline

[ Price : $8.95]

Four stakeholder groups suggest revisions to an FDA publication of the ICH E6(R3) good clinical practice guideline.

ISO 10993-1 Clarifying Guidance

[ Price : $8.95]

FDA publishes a guidance clarifying and updating information on using ISO 10993-1 in preparing medical device submissions to FDA.

No Marketing of Same Rx and OTC Drugs: Reps

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A bipartisan group of three House members asks CDER to remove the simultaneous marketing provision from a proposed rule on Rx to O...

Philips $615 Million Settlement Over Faulty Devices

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Philips Respironics announces it has set aside $615 million under an agreement to resolve all economic loss claims in a class acti...

Guide on Endogenous Cushings Syndrome

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FDA releases a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatment.

Janssen Stops Macitentan Phase 3 Study

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Janssen Pharmaceutical discontines, due to futility, its Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with chron...

CymaBay Therapeutics Plans NDA for Seladelpar

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CymaBay Therapeutics says it will seek FDA approval for seladelpar for treating adult patients with primary biliary cholangitis af...

2 Priority Review Vouchers Issued

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Federal Register notices: FDA issues two priority review vouchers to sponsors whose recent product approvals met the criteria (rar...

FDA Update on Bone Matrix TB Issue

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FDA says it is working with the CDC to investigate cases of TB associated with a bone matrix product.

3 Draft Guides on 510(k) Devices

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Federal Register notice: FDA releases three draft guidances that are intended to improve the predictability, consistency, and tran...