FDA Offers 'Rapid' Help As Stem Cell Approval Deadline Nears

Law360 (June 12, 2019, 8:54 PM EDT) -- The U.S. Food and Drug Administration on Wednesday offered to give "rapid" feedback to stem cell clinics that solicit its views on how their treatments would be regulated in an effort to jump-start inquiries by clinics that have largely ignored an approaching deadline to seek agency approval.

The FDA's offer came in the form of a new program that will last until the end of 2019 and allow stem cell companies to get preliminary assessments of how their products would likely be regulated. Clinics would receive assessments within three business days of inquiring.

Dubbed the Tissue Reference Group Rapid Inquiry Program,...

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