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Experts Dismiss FDA Drug Development Tools Program

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Genentech researchers say FDAs Drug Development Tools Qualification program has had a very limited impact on development programs....

Lab Test Ruling Could Apply to AI at FDA: Researchers

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Public health researchers warn about the broader impacts to emerging technologies (e.g., artificial intelligence) in a March court...

ImmunityBio sBLA Filing Refused on Expanded Indication

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FDA sends ImmunityBio a refusal to file letter for its recent supplemental BLA submission seeking approval for Anktiva plus Bacill...

Capricor Therapeutics Passes Mid-Cycle Review

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Capricor Therapeutics says it has completed an FDA mid-cycle review meeting on a BLA seeking approval for deramiocel and its use i...

FDA Rejects CytoSorbents Bleed Reducing Device

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FDA denies a CytoSorbents de novo marketing request for its DrugSorb-ATR antithrombotic removal system, intended for reducing the ...

MR Contour DL Model Cleared for Organ Segmentation

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FDA clears a GE HealthCare 510(k) for its MR Contour DL, an artificial intelligence model that uses deep learning for organs-at-ri...

Agency Accepts Oral Wegovy NDA for Obesity

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FDA acccepts for review a Novo Nordisk NDA for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight man...

FDA Rehiring Freedom of Information Staff

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FDA rehires some Freedom of Information office workers who were terminated under White House-mandated reduction-in-force cuts.

FDA Withdraws and Reissues 2 Guidances

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FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissuing them in draft form to add c...

Petition Seeks to Restrict Da Vinci Off-Label Use

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A citizen petition asks FDA to restrict the off-label use of the Da Vinci Robotic System and video-assisted thoracoscopy devices t...