BIO Comments on Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
October 16, 2018
BIO submitted comments to the National Institutes of Health (NIH) regarding the Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
BIO applauds the NIH’s efforts to support and advance drug development for gene therapies, by streamlining protocol registration and reporting requirements and by modifying the roles and responsibilities of the Recombinant DNA Advisory Committee. BIO agrees with the goal to eliminate duplication and excess in regulation of gene therapy products, as these redundancies do not exist in most other areas of clinical research. BIO believes there is sufficient and robust regulatory framework already in place for safe and effective development of gene therapy products.
BIO also proposes changes to the requirement for an Institutional Biosafety Committee (IBC) approval of a study site before initiation of a study.
Download Full Comments Below
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BIO submitted comments to the National Institutes of Health (NIH) regarding the Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
BIO applauds the NIH’s efforts to support and advance drug development for gene therapies, by streamlining protocol registration and reporting requirements and by modifying the roles and responsibilities of the Recombinant DNA Advisory Committee. BIO agrees with the goal to eliminate duplication and excess in regulation of gene therapy products, as these redundancies do not exist in most other areas of clinical research. BIO believes there is sufficient and robust regulatory framework already in place for safe and effective development of gene therapy products.
BIO also proposes changes to the requirement for an Institutional Biosafety Committee (IBC) approval of a study site before initiation of a study.