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Guide on Recurrent Herpes Labialis Drug Development

[ Price : $8.95]

FDA posts a guidance on Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention that discusses the overall develo...

FDA Reclassifies Sharps Needle Destructors Into Class 2

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Federal Register proposed order: FDA proposes to reclassify the needle destruction device, renaming the device to sharps needle de...

Harris Probing Alkermes Vivitrol Sales

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Sen. Kamela Harris says she is investigating efforts by Alkermes to artificially boost sales of its Vivitrol opioid addiction trea...

Vitamin D Mass Spectrometry Test Put Into Class 2

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Federal Register notice: FDA classifies the total 25-hydroxyvitamin D mass spectrometry test system into Class 2 (special controls...

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...