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Will FDASIA Slow Things Down?

 
• By Bridget Silverman

During Elsevier Business Intelligence’s FDA/CMS Summit in December, FDA Office of New Drugs Director John Jenkins discussed the possible impact of the FDA Safety and Innovation Act, as compared to the significant burden posed by implementation of the 2007 FDA Amendments Act.

While the implementation of the FDA Amendments Act meant changes so significant the agency stopped focusing on meeting review deadlines, the simpler adjustments under 2012’s FDA Safety and Innovation Act should not be as disruptive, Office of New Drugs Director John Jenkins told Elsevier Business Intelligence’s FDA/CMS Summit Dec. 10.

FDASIA’s new review model for NMEs and novel BLAs, which Jenkins calls “the program,” is “a major new addition” to CDER’s review architecture, he said, but “the individual components are...

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