EveryLife Foundation Workshop #4: Developing Guidance and Policy Recommendations for Accelerated Approval in Rare Diseases

Please save the date for the next workshop in the Rare Disease Workshop Series:  Thursday, November 15, 2012 at the Sofitel Hotel in Washington DC.

 Now is the ideal time to establish policy and guidance recommendations on Accelerated Approval in rare diseases. The Food and Drug Administration Safety and Innovation Act, S. 3187, which was signed by the President in July, includes the need to develop a guidance on the implementation of updated Accelerated Approval practices.

 “Considerations. – In developing the guidance . . . . the Secretary shall consider . . . . for drugs designated for a rare disease or condition under section 526 of the Federal, Food, Drug, and Cosmetic Act; and

(2)how to incorporate novel approaches to the review of surrogate endpoints based on pathophysiologic and pharmacologic evidence in such guidance, especially in instances where the low prevalence of a disease renders the existence or collection of other types of data unlikely or impractical.”

                                    — Food and Drug Administration Safety and Innovation Act

Working together, industry, academia, FDA, NIH and other stakeholders can offer well-reasoned, scientifically sound, and realistic policy recommendations that will accelerate the development of rare disease treatments.

Registration is open now. To register please click here  

Accommodations:

We have secured a guest room group rate of $310 for Superior King room at the Sofitel Hotel Washington DC Lafayette Square.
To make a reservation please:
Call Sofitel reservations at (202) 730-8800, ask for “group reservations” and identify yourself as a member of the “EveryLife Foundation for Rare Diseases” group.
Please make hotel reservations by October 22, 2012, the group rate cut-off date.
No online reservations for group rate.