FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Gottlieb, Marks Explore Regulatory Pathways for Stem-Cell Development

March 12, 2018

The FDA plans to make tools available to provide incentives for doctors or physician groups to collaborate on stem-cell and regenerative medicine products, eventually leading to a biologics license for each doctor or group, CBER Director Peter Marks and Commissioner Scott Gottlieb said in a New England Journal of Medicine article published Thursday.

Pooled safety and efficacy data from the various sites that are participating in the trial “will be submitted as part of a biologics license application for each.”

If the clinical data the applicants submit show a favorable risk-benefit profile, the FDA could use the data to help determine the product’s safety and efficacy.

This system could be particularly convenient for groups or small firms that can follow common clinical and manufacturing standards but do not have access to the necessary infrastructure or patient populations to go through the clinical development process alone.

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