Sec. 7. Supporting innovation in regenerative medicine through cures acceleration network
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Section 480 of the Public Health Service Act ( 42 U.S.C. 287a ) is amended— in subsection (d), by adding at the end the following: With respect to activities of the Board relating to medical products and behavioral therapies for use in regenerative medicine, the Board shall collaborate with the Regenerative Medicine Coordinating Council. ; and in subsection (e)(3), by adding at the end the following: The Director of NIH may, without regard to subparagraphs (A), (B), and (C), provide assistance under paragraph
(1)with respect to medical products and behavioral therapies for use in regenerative medicine, including assistance— to perform clinical trials under a protocol approved by the Commissioner of Food and Drugs or studies which use good manufacturing practice or good laboratory practice procedures and the data from which are intended for inclusion in an investigational new drug application or an investigational device exemption application; or to perform basic research or preclinical studies in regenerative medicine the data from which are not intended for inclusion in an investigational new drug application or an investigational device exemption application. .
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Sec. 7
Supporting innovation in regenerative medicine through cures acceleration network
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