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FDA document outlines apparent agency support for full approval of Biogen, Eisai's Leqembi

Fierce Pharma

On Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug. . | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval.

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STAT+: FDA reviewers had string of concerns about Sarepta’s gene therapy for Duchenne, documents show


Reviewers at the Food and Drug Administration concluded that Sarepta Therapeutics did not show that its gene therapy for Duchenne muscular dystrophy will likely benefit patients and left key safety concerns, according to briefing documents released Wednesday.

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Documentation Pays Off in More Than Way Than One

Drug Topics

Quality documentation ensures that pharmacies get paid for clinical services and offers a way to engage with patients.

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Incoming Documents and Faxes


Save valuable time in your workflow with the Incoming Documents and Faxes tool, available in PioneerRx’s pharmacy software.…

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NICE publishes Final Appraisal Document for multiple myeloma drug


The National Institute for Health and Care Excellence (NICE) has submitted a Final Appraisal Document (FAD) for the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. read more

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Juul agrees to pay $462 million to 6 states and D.C., and to share documents


The settlement, which includes California and New York, is the largest to date between Juul and state attorneys general, and will also require Juul to disclose a number of previously secret documents, which will be housed in an academic archive. Read the rest…

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Presentation of Controlled Documents with Paperless Validation Systems


Background In paper based CQV programs, the inspection process focuses on reports and execution binders; the reports summarize the conclusions of a specific study, and the execution binder provides the documented evidence used to support the conclusions in the report. Can you describe the audit trail features of this application?