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In December 2014, the Senate approved a bill that would add the Ebola virus to the Priority Review Voucher List. [23] The bill, S. 2917— Adding Ebola to the FDA Priority Review Voucher Program Act , was introduced by Senator Tom Harkin on November 12, 2014.
Title XI also created the priority review voucher program. This requires the FDA to award a transferable, priority review voucher to the sponsor of a tropical disease product application upon approval by the Secretary of such application and establish a priority review user fee program.
The U.S. Food and Drug Administration priority review voucher is an incentive for companies to invest in new drugs and vaccines for tropical diseases. A provision of the Food and Drug Administration Amendments Act of 2007 awards a transferable "priority review voucher" to any company that obtains approval for a treatment for one of the listed ...
The FDA's tropical disease priority review voucher program is intended to encourage the development of new drugs for the prevention and treatment of tropical diseases. The vouchers shorten the ...
bluebird (BLUE) is set to sell one of its two priority review vouchers. This will strengthen its financial position as its existing cash balance is expected to exhaust by second-quarter 2023.
Elon Musk and Vivek Ramaswamy wrote an op-ed detailing their vision for cutting government costs. One of their targets is a list of programs with expired funding authorization totaling $516 billion.
To extend the pediatric priority review voucher program Pub. L. 114–229 (text) 114-230: October 7, 2016 Korean War Veterans Memorial Wall of Remembrance Act: To authorize a Wall of Remembrance as part of the Korean War Veterans Memorial and to allow certain private contributions to fund that Wall of Remembrance Pub. L. 114–230 (text)
After passing phase III clinical trials, Eli Lilly applied to the U.S. Food and Drug Administration (FDA) for approval in 2021, with a priority review voucher. [ 39 ] After completing the SURPASS-2 trial (NCT03987919), the company announced in April 2022 that tirzepatide had successfully met its clinical endpoints in obese and overweight ...