Seven Rare Disease Therapies Chosen for FDA START

The FDA has selected seven rare disease therapies to participate in its Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to accelerate the development of novel drug products through, in part, enhanced communications with the agency.

START — unveiled last September and developed by CBER’s Office of Therapeutic Drugs and CDER’s Office of New Drugs — is designed to provide enhanced communications to the selected sponsors of products in clinical trials. The program also is intended to facilitate more efficient development of potentially life-saving and life-changing therapies with rare disease indications and provide a mechanism for addressing clinical development issues.

According to the FDA, the selected START participants will be able to obtain frequent advice and regular ad-hoc communication with agency staff to address product-specific developmental issues, including but not limited to clinical study design, choice of control group and fine-tuning the choice of patient population.

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