Rationing Of Genzyme’s Myozyme In Europe Likely Through April Due To Supply Constraints

Until approval of the larger 4000 L bioreactor for the Pompe Disease product, EMEA recommends priority access for infants, children and adolescents.

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Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

Recent and Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.