Choice Of Regulatory Pathway Is Key Inflection Point In Drug Reviews

 
• By Bridget Silverman

A year of Drug Review Profiles in the Pink Sheet shows how important the choice of regulatory pathway has become to drug development and approval.

The proliferation of regulatory pathways gives FDA a powerful way to set priorities and shape drug development, an overview of the Pink Sheet's Drug Review Profile series shows.

Multiple reauthorizations of the Prescription Drug User Fee Act and decades of regulatory experience have built a complicated edifice of...

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