Magazine Article | January 1, 2017

Cell Therapy Regulations Approach Their Inflection Point

By Gail Dutton, Contributing Editor
Follow Me On Twitter @GailLdutton

The need for discussions regarding guidelines for the development of therapeutics made from human cells, tissues, and cell- and tissue-based products has been building for a long time.

That need was evidenced by introduction of the REGROW Act (S. 2689/HR 4762) in Congress last spring, which tries to streamline commercialization of cell therapeutics, and by two days of public FDA hearings this past fall to clarify guidelines for cell-based therapeutics. “There’s a huge wave of interest from patients, patient advocates, and the drug development industry,” says Karine Kleinhaus, M.D., divisional VP for North America at Pluristem Therapeutics.

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