Proposals for Modernizing IND Processes, Clinical Trial Development, and Good Clinical Practice Standards
In an effort to encourage continued discussion between and within our biopharmaceutical community and the regulatory bodies we collaborate with, RA Capital Management has submitted several recommendations to the US Department of Health and Human Services and the Food and Drug Administration to help the agencies as they continue to modernize their processes to benefit the American public.
We expect that an ongoing dialogue between industry and the agencies will benefit the evolving US biomedical regulatory and innovation framework.
Our recommendations were gleaned with input from experts across our portfolio companies, employees of our firm, and our advisors. We present them here to foster discussion within our community about what could be better (in the spirit of our Semper Maior series).
And we encourage others to contribute their ideas directly or share them with us to relay. We’ll update this living document from time to time as new ideas come to light or nascent ones become actionable (we have additional ideas to include when we determine a clear path to operationalizing them).
We look forward to continued feedback and engagement with our biopharma industry community and our regulators.