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FDA Credits 2019 Cybersecurity Work

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FDA lists six of its 2019 activities to promote medical device cybersecurity safety and awareness.

Shreis Wins Breakthrough for Tissue Control Device

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FDA grants Shreis Scalene Sciences a Breakthrough Device designation for Cytotron, a whole-body therapeutic medical device for use...

FDA Grants Recro Meloxicam Appeal

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FDA grants Recro Pharmas appeal of an agency complete response letter for the firms IV meloxicam.

ICU Medical Recalls 2 Products Over Particulate Matter

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ICU Medical recalls one single lot of lactated ringers injection, USP, and one single lot of 0.9% sodium chloride injection, USP, ...

CARsgen Gains Regenerative Medicine Advanced Therapy Status

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FDA grants CARsgen Therapeutics a Regenerative Medicine Advanced Therapy designation for its investigational CT053 CAR-T cell ther...

Draft Guide on IND Safety Report eSubmissions

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Federal Register notice: FDA makes available a draft guidance on Providing Regulatory Submissions in Electronic Format: IND Safety...

Panel Split on Makenas Withdrawal After Failed Study

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In a split vote, FDAs Bone, Reproductive and Urologic Drugs Advisory Committee votes 9 to 7 to recommend that the agency remove fr...

Interim Compounding with Bulk Substances Policy

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FDA issues a guidance on an interim regulatory policy for outsourcing facilities compounding drugs from bulk drug substances.

FDA Partial Hold on Novartis/AveXis AVXS-101 Trials

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FDA puts a partial hold on intrathecal clinical trials of Novartis/AveXis AVXS-101.

Innovative Wants Restrictions on IB-Stim Equivalence

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Innovative Health Solutions asks FDA to require preclinical studies and at least one clinical trial to demonstrate substantial equ...