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Latest From Eisai Co., Ltd.

US FDA and ARPA-H: Woodcock Has Questions

The FDA’s principal deputy commissioner wonders how the agency will work with ARPA-H to help get its projects to patients and the health care system given its other responsibilities.

Research & Development Legislation

Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks

Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.

Gene Therapy Review Pathway

Preliminary Remediation Begins On Restarting Formula Production At Abbott Nutrition Plant

Decree imposes steps Abbott must complete before it can begin preparing to restart production, including hiring independent consultant to determine whether facility is compliant with FDA manufacturing and labeling regulations.

FDA Enforcement

Before Infant Formula Recall, Abbott ‘Closed-Done’ With Investigation Complaint Referencing Death

FDA report on inspection states Abbott and agency “found evidence" of Cronobacter species bacteria in powdered infant formula production environment and firm also identified bacteria in finished powdered formula products. Once Abbott gets FDA clearance to restart production at facility, it will need as much as two months before formula made there reaches stores.

FDA Safety
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