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Becker's Healthcare September 25, 2025
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,...
