25 July 2018 - The US FDA on Wednesday published a list of surrogate outcomes to help inform drug developer discussions with relevant Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research review divisions.

The list, which was created thanks to the 21st Century Cures Act, includes surrogate outcomes that sponsors have used as primary efficacy clinical trial outcomes for approval of new drug applications (NDAs) or biologics license applications (BLAs). It also includes surrogate outcomes that may be appropriate for use as primary efficacy clinical trial outcomes for drug or biologic approvals, although they have not yet been used to support an approved NDA or BLA.

The list, which will be updated every six months, features surrogate outcomes for numerous diseases including acromegaly, different cancers, chronic kidney disease, cystic fibrosis, hepatitis A, B and C, HIV, hypertension and osteoporosis, among others.

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