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Latest FDA Warning Letters

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In its latest batch of Marck Biosciences, Nidek, Spacelabs Healthcare, Gilbert A. Weiner, and Wickliffe Pharmaceutical.

FDA Making Open Access to MAUDE Data Available

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CDRH director Jeffrey Shuren and FDA chief health information officer Taha Kass-Hout tout release of the latest openFDA programmin...

Guidance on FDA Decisions for IDE Investigations

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Federal Register Notice: FDA releases a guidance: FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations...

Workshop on Brain-Computer Interface Devices

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Federal Register Notice: FDA plans a public workshop 11/21 on brain-computer interface devices for patients with paralysis and amp...

Genzyme Cerdelga NDA Approved for Gaucher Disease

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FDA approves a Genzyme NDA for Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher...

Hearing On Generic Drug User Fees

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Federal Register Notice: FDA plans a public hearing 9/17 on certain topics related to implementation of the Generic Drug User Fee ...

Law Firm Urges Industry to Reject 510(k) Benefit-Risk Guidance

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Duval & Associates urges the Advanced Medical Technology Association (AdvaMed) and Medical Device Manufacturers Association to opp...

Boxed Warnings Becoming More Prevalent on Drugs: Researchers

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Researchers writing in the 8/15 issue of JAMA Internal Medicine say boxed warnings on drugs are becoming more common.

CDER Drug Safety Board Reviews Anticoagulants

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CDERs Drug Safety Oversight Board reviews safety implications from new generation anti-coagulants.

Editorial Wants FDA Out of Compassionate-use Approvals

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A USA Today editorial argues for quicker and less cumbersome no FDA role compassionate-use opportunities for patients suffering ...