HHS is taking new steps to speed the development and review of new cell and gene therapies in the U.S.
Three things to know:
1. The FDA published three draft guidances Sept. 24 detailing strategies for drugmakers to streamline the development and approval of drug candidates to treat rare diseases that affect a small population of patients.
2. The documents promote the use of innovative clinical trial designs, outline paths for accelerated approval of certain regenerative therapies and clarify requirements for post-approval safety and efficacy monitoring.
3. The Advanced Research Projects Agency for Health, or ARPA-H, also launched two programs aimed at increasing access to affordable genetic medicines. One program focuses on accelerating development of one-time precision treatments for genetic diseases, while the other supports new biomanufacturing technologies to make these therapies faster and cheaper to produce.
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