-
The Promising Pathway Act
Hi All,
I just heard of the The Promising Pathway Act. This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases. The period of the provisional approval is for two years and is potentially renewable. The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations.
https://www.congress.gov/bill/116th-congress/senate-bill/3872
Perhaps if contacting your state senate representatives, faster action may occur.
Richard
Log in to reply.