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Accelerated Approval Mulled for Biogens Tofersen

[ Price : $8.95]

FDA reviewers appear open to considering accelerated approval for Biogens amyotrophic lateral sclerosis drug tofersen in patients ...

Guide on Clinical Trial Electronic Records

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Federal Register notice: FDA makes available a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Sign...

Ipsen NDA Resubmission for Palovarotene

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FDA accepts for review an Ipsen resubmitted NDA for palovarotene as a potential treatment for fibrodysplasia ossificans progressiv...

Sarepta BLA Needs Panel Review: FDA

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FDA tells Sarepta Therapeutics that it has decided to hold an advisory committee meeting to review its gene therapy BLA for SRP-90...

Guide on Pharmacogenomic Data Submissions

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FDA posts a draft guidance entitled Pharmacogenomic Data Submissions that discusses the use of such data in drug development.

CDER Regulatory Site Tours Continue

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Federal Register notice: CDER announces the continuation of its Regulatory Project Management Site Tours and Regulatory Interactio...

FDA Hits Olympus with Warning Letter

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FDA issues Olympus Medical Systems a Warning Letter after inspecting the firms Tokyo facility and documenting GMP deficiencies.

Court OKs $25 Million Remicade Settlement

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A federal judge approves a $25 million class action settlement involving Johnson & Johnsons Remicade (infliximab).

CDER Posts Annual Office of Compliance Report

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CDER posts its Office of Compliance Annual Report for fiscal year 2022.

Datascopes Cardiosave Heart Pumps Recalled

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Datascope/Getinge recalls Cardiosave Hybrid IABPs and Rescue IABPs because the coiled cable connecting the display and base on som...