FDA Expanding Accelerated Approval Through Guidance, Collaboration

Disease communities will have to be engaged in developing endpoints needed to make accelerated approval happen for more drugs; FDA acknowledges that the pathway is “underutilized in many areas.”

FDA plans to write guidance to clarify for sponsors when accelerated approval is appropriate and to revisit the standards of evidence needed to support that approval pathway as congressional interest grows in expanding the program.

The program for speeding approval of drugs before the full extent of the efficacy and safety is known has been very successful for drugs to treat HIV and cancer and...

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