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Impact of FDA China Cell Rule Unclear: Experts

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Experts share varying opinions with Clinical Trials Arena on the impact of an FDA rule barring biotech companies from sending cell...

Stop Inaccurate Health Info: HHS Staff to RFK, Jr.

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Some 750 current and former HHSers call on secretary Robert F. Kennedy, Jr., to protect them and the rest of his staff from attack...

FDA Updates Breakthrough Device Statistics

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Updated medical device breakthrough device designation metrics show 1,176 approvals since 2015 and 160 marketing authorizations.

FDA DrugSorb-ATR Options

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FDA suggests ways CytoSorbents can proceed with its de novo application for DrugSorb-ATR.

Act Against Compounded Semaglutide: Petition

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Wiley Rein petitions FDA to take seven specific actions to address public health risks associated with compounded semaglutide drug...

2 Eylea HD Submissions Get Review Extensions

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FDA extends until the fourth quarter the review of two Regeneron Pharmaceuticals regulatory submissions for Eylea HD (aflibercept)...

B. Braun Recalls 2 Drugs Over Particulate Matter

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B. Braun Medical recalls (Class 1) one lot each of its Lactated Ringers Injection USP 1,000 mL and 0.9% sodium chloride injection...

CGMP Violations Seen in Anhui Hanbon Inspection

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FDA warns Chinas Anhui Hanbon Daily Chemical Co. about CGMP violations in its production of finished drugs.

FDA Pushes Back Review of Hunter Syndrome BLA

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FDA extends by 90 days its review of a Regenxbios BLA for RGX-121 (clemidsogene lanparvovec), an investigational gene therapy for ...

PTC Therapeutics Friedreichs Ataxia Drug Rejected

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FDA rejects a PTC Therapeutics NDA for vatiquinone and its use for treating Friedreichs ataxia, saying additional evidence of the ...