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Class 2 for Recessive Carrier Screening Gene Mutation Detectors

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Federal Register final order: FDA exempts from premarket notification requirements autosomal recessive carrier screening gene muta...

FDA Denies Millennium Velcade Petition

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FDA denies a Millennial Pharmaceuticals petition seeking to put limits on ANDA or 505(b)(2) applications referencing its Velcade.

FDA Oncology Center of Excellence Site-Agnostic Approval

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FDA Oncology Center of Excellence staffers say they are optimistic about the future of oncology drug development after approving t...

FDA Lifts Clinical Hold on Cellectis UCART 123

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FDA lifts its clinical hold on a Cellectis investigational cancer drugs Phase 1 trials.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Biomin Industries and Guangdong Zhanjiang Jimin Pharmaceutical Co.

CDRH Role in Device Trial Design Should be Disclosed: JAMA

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A JAMA viewpoint piece urges medical journal editors to encourage study authors to disclose CDRHs role in clinical trial design an...

Guide on OTC Aspirin Labels Using Heart Imagery

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FDA posts a guidance on Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Re...

FDA Guidance on Hep C Drug Development

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FDA releases a guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.

Guide on Scientific Dispute Resolution

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Federal Register notice: FDA makes available a guidance on Formal Dispute Resolution: Sponsor Appeals Above the Division Level.

Draft Guide on ANDA Pre-submission Facility Info

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Federal Register notice: FDA makesavailable a revised draft guidance entitled ANDAs: Pre-Submission of Facility Information Relate...