By Julia Jenkins, EveryLife Foundation Director of Government Relations We are very excited to share the news that rare disease Accelerated Approval language made it into the House draft PDUFA bill. The language that incorporates the goals of ULTRA is the only mention of rare diseases in the entire 205-page bill. This is a huge […]
Report to Congress: Improving the Prevention, Diagnosis, and Treatment of Rare and Neglected Diseases In Response to the Brownback/Brown Amendment, Section 740 The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriation Act, 2010 Department of Health & Human Services: Food and Drug Administration, March 2011 INTRODUCTION Section 740 of the fiscal year (FY) 2010 Appropriation Act […]
The Cures Acceleration Network (CAN) was authorized to advance the development of high need cures and reduce significant barriers between research discovery and clinical trials. To achieve these objectives, CAN provides the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) with new flexibilities in its funding authorities.
On November 7, 2002, the White House announced that President Bush signed into law the Rare Diseases Act (H.R. 4013) and the Rare Diseases Orphan Product Development Act (H.R. 4014). Originally introduced in August 2001 by Senators Edward Kennedy (D-MA) and Orrin Hatch (R-UT) the Rare Diseases Act of 2001 (S. 1379) was later split into […]
In 1992, Congress first enacted the Prescription Drug User Fee Act (PDUFA) which collects fees from drug manufacturers. The FDA uses the additional revenue stream to hire more staff with the goals of: More efficient and timely review of license applications, and Increase their medical and scientific expertise. The law was authorized for five years and has been reauthorized […]
111TH CONGRESS 1ST SESSION H. R. 5238 IN THE HOUSE OF REPRESENTATIVES December 15, 1981 Mr. Waxman introduced the following bill; which was referred to the Committee on Energy and Commerce