FDA Facilitates the Use of Surrogate Endpoint in Drug Development

CDER small business and industry assistance podcast news from November 2018

To enhance the use of surrogate endpoints (SEs) in drug development, expand existing transparency initiatives, and facilitate the development of new and innovative products for patients, the FDA has made available additional resources for drug development programs intending to use SEs. One such resource is the Table of Surrogate Endpoints (SEs) That Were the Basis of Drug Approval or Licensure for both traditional and accelerated approval. This table lists SEs the FDA has accepted or could accept as primary efficacy endpoints in drug development programs. In addition, the FDA is also accepting Type C IND meeting requests focused on potential novel SEs that may be used in drug development programs.

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