Topic: Bill to Expedite Development of Therapies for Patients with Unmet Medi
This is important news for us. Finally we might now see quicker approval for drugs beneficial to Cholangiocarcinoma Patients.
FAST Act Introduced by Representatives Stearns and Towns
Proposed legislation introduced this week by Representatives Cliff Stearns (R-FL) and Edolphus (Ed) Towns (D-NY) is developed in order to accelerate the development of innovative therapies for people with serious or life-threatening diseases.
H.R. 4132, Faster Access to Specialized Treatments or the FAST Act, is designed to modernize and expand the Food and Drug Administration's Accelerated Approval pathway to encompass a broader range of diseases and encourage innovative drug development tools and strategies.
Stearns and Towns have introduced legislation to speed the approval of new therapies for patients with serious and life-threatening diseases. The bill also provides further clarity of the FDA approval process by codifying and modernizing the well-established Accelerated Approval program.
"Accelerated Approval" refers to a pathway at FDA for earlier approval of drugs for serious, unmet medical need. Surrogate endpoint or marker predicting clinical benefit must be tested to verify the anticipated benefit.