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FDA Accepts BioMarin BLA for Gene Therapy

[ Price : $8.95]

FDA accepts for review a BioMarin BLA resubmission for gene therapy valoctocogene roxaparvovec for adults with severe hemophilia A...

Agency Seeks Consumer Reps on Advisory Committees

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Federal Register notice: FDA seeks consumer organizations that are interested in participating in selecting voting and nonvoting c...

Dietary Supplement GMPs Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Current Good Manufacturing Practice in...

CMS Working with FDA on New Device Coverage Rule

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Two Centers for Medicare and Medicaid Services officials describe the principles in a new coverage rule for innovative medical dev...

Exela Pharma Recalls 49 Sodium Bicarbonate Lots

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Exela Pharma Sciences (Lenoir, NC) recalls 49 lots of sodium bicarbonate injection due to safety concerns.

FDA Revamping NDA/BLA Information Requests

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FDA seeks public comments on a Statement of Work mandated by the recent drug user fee reauthorization to assess communication betw...

Three Charged with Falsifying Clinical Trial Data

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A Miami grand jury charges three defendants for their roles in an alleged scheme to fabricate and falsify clinical drug trial data...

FDA Publishes ICH E19 Guideline

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FDA publishes the International Council for Harmonization E19 guideline on selective safety data collection in some circumstances.

FDA Seeks Covis Info for Makena Hearing

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CDER asks an FDA hearing officer to direct Covis to provide additional information on items from its final briefing materials for ...

GSK Respiratory Syncytial Virus Vaccine Highly Efficacious

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GlaxoSmithKline says its investigational adult respiratory syncytial virus vaccine candidate was highly effective in a Phase 3 tri...