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GAO Report Probes Device DTC Advertising

[ Price : $8.95]

In what is a likely sign of increasing interest on Capitol Hill, the Government Accountability Office releases a new report examin...

Panel to Review Merck Cough Drug

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Federal Register notice: FDA announces an 11/17 Pulmonary-Allergy Drugs Advisory Committee to review a Merck NDA for gefapixant or...

Meeting on Kidney Transplant Rejection Drugs

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Federal Register notice: FDA plans an 11/9 public meeting entitled Endpoints and Trial Designs to Advance Drug Development in Kidn...

Danco Seeks High Court Abortion Drug Review

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Abortion drug distributor Danco Laboratories petitions the U.S. Supreme Court to review last months decision by the Fifth Circuit ...

Human Factors Engineering Q&A Guidance

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FDA publishes a guidance with questions and answers on applying human factors engineering principles in developing combination dru...

Suggestions for ICH Good Clinical Practice Guideline

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

ISO 10993-1 Clarifying Guidance

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FDA releases a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatment.