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Tremeau Gains FDA Agreement to Develop Withdrawn Drug

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Tremeau Pharmaceuticals says it has recently reached agreement with FDA on the development requirements to support an NDA for TRM-...

Web Site Established on Susceptibility Test Criteria

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Federal Register notice: FDA establishes a Susceptibility Test Interpretive Criteria Web site that is intended to help efficiently...

FDA Approves Boston Scientific Brain Stimulator

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FDA approves a Boston Scientific PMA for the Vercise Deep Brain Stimulation System and its use for treating symptoms of Parkinsons...

Use New Regulations to Ease Regulatory Burden: MIWG

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The Medical Information Working Group says there are instances in which industrys regulatory burden could be eased through additio...

Noroxin Not Withdrawn Due to Safety/Effectiveness: FDA

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Federal Register notice: FDA determines that Mercks Noroxin (norfloxacin) tablets, 400 mg, was not withdrawn due to safety or effe...

FDA Deceptive Ad Recognition Research Advancing

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FDA asks the Office of Management and Budget to review its proposal for two studies determining how well consumers and healthcare ...

CGMP, Labeling Violations at Koreas Seindni Company

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FDA warns Koreas Seindni Company about CGMP and labeling violations in its manufacturing of finished drug products.

FDA Drug Product Gluten Recommendations

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FDA releases a draft guidance with recommendations on how to include information on gluten content in certain drug products.

Number of Early Feasibility IDEs More Than Double

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CDRH staffers say the number of IDEs submitted for early feasibility studies has more than doubled in the second year of the progr...

NDA, BLA Refuse-to-File Guidance

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FDA issues a draft guidance explaining some circumstances under which the agency may refuse to file a new or supplemental NDA or B...