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FDA Revokes EUAs on 2 Covid Tests

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FDA revokes a Bio-Rad Laboratories Emergency Use Authorization (EUA) and a Bio- Applied DNA Sciences EUA for their no-longer-distr...

Guidance on Considerations for Drug Quality Assessments

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FDA posts a draft guidance entitled Benefit-Risk Considerations for Product Quality Assessments, which describes the agencys benef...

Draft Guide on Cybersecurity for Legacy Devices

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The International Medical Device Regulators Forum (IMDRF), of which FDA is a member, seeks comments on a proposed guidance entitle...

FDA Not Delaying Pediatric Covid Vaccines: Marks

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CBER director Peter Marks tells a House briefing that FDA is not delaying its review of Modernas Covid-19 vaccine for children und...

LogicBio Clinical Hold Lifted by FDA

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FDA lifts a clinical hold on LogicBio Therapeutics Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with me...

Istodax T-cell Lymphoma Indication Withdrawn

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Federal Register notice: FDA announces that it is withdrawing approval of Bristol Myers Squibbs (Celgene) peripheral T-cell lympho...

Drug Compounding Panel Discussing 4 Bulk Drugs

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Federal Register notice: FDA announces a 6/8 Pharmacy Compounding Advisory Committee meeting to discuss four bulk drug substances ...

Guide on Device Quality Improvement Program

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Federal Register notice: FDA makes available a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and En...

Draft Guide on Testosterone ANDA Bioequivalence

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Federal Register notice: FDA makes available a revised draft guidance entitled Draft Guidance for Testosterone.

Toxic Risk with Fresenius Hemodialysis Machines: FDA

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FDA warns about the potential risk of exposure to toxic non-dioxin-like polychlorinated biphenyl acids and polychlorinated bipheny...