Rep. Michael C. Burgess, MD (R-Texas) and Rep. Brett Guthrie (R-Ky.) both believe the FDARA contains provision that not only bring more low-cost generic options to the marketplace, but also make the clinical trial process more patient-oriented.
The programs protected by passage of the act include the Generic Drug User Fee Amendments, the Prescription Drug User Fee Amendment, the Biosimilar User Fee Amendments and the Medical Device User Fee Amendments.
Already passed through the House’s Health Subcommittee, the bill will be presented for passage through the full committee for a vote Wednesday.
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