NIH RACNational Institutes of Health Recombinant DNA Advisory Committee
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Sound and humane public policy would see the NIH RAC repeal Appendix M and announce its intention to consider carefully crafted human germline gene therapy proposals that meet community standards for risk-benefit.
Under the agreement, Takara and Penn will jointly pursue an IND application, in particular pre-clinical studies including animal tests and GMP manufacturing scale-up, regulatory submission to the Recombinant DNA Advisory Committee of the National Institutes of Health (NIH RAC), pre IND meetings with FDA, and preparation and submission of documents for the IND application.