Tag: pdufa

A total of 10 posts are filed under pdufa
John Crowley Talks About the Fifth Prescription Drug User Fee Act
On the last day of the World Orphan Drug Congress, John Crowley, Chairman and CEO, Amicus Therapeutics provided an inspiring overview of how… Continue Reading
FDA User Fee Bill Is Landmark Legislation – Major Wins for the Rare Disease Patient Community Led by RDLA
Wednesday, June 27, 2012, Washington, DC — Rare Disease Legislative Advocates (RDLA) hails House and Senate passage of The Food and Drug… Continue Reading
HR 5651, the Food and Drug Administration Reform Act of 2012
House FDA User Fee Bill Will Unlock Lifesaving Treatments for Rare Diseases Rare Disease Community Applauds House Energy & Commerce… Continue Reading
PDUFA Update and Accelerated Approval Program For Rare Diseases
We’re continuing to work on improving PDUFA to allow the FDA additional authority to include rare diseases in the Accelerated Approval… Continue Reading
RARE ACTION ALERT – Accelerated Approval to treatments for rare disease patients
The Global Genes Project and R.A.R.E. team have been working with Rare Disease Legislative Advocates (RDLA) on legislative improvements that… Continue Reading
Legislative Advocates Conference Call: PDUFA Update
Please join us for a Conference Call on Wednesday, March 28, 2012 at 1:00 p.m. Eastern Draft Agenda: Update the Prescription Drug User… Continue Reading
Rare Disease Language included in House draft PDUFA Bill
RARE Project would like you to consider taking action in support of the new language (FAST Act) related to the Prescription Drug User Fee… Continue Reading