EXPANDED ACCESS UPDATE – DEVELOPMENTS AT THE FDA AND BEYOND

In June 2016 the FDA released three new guidance documents, including a “Questions and Answers” clarifying the responsibilities of both drug manufacturers and the FDA for navigating “compassionate use” requests for drugs that have not yet been approved by the FDA. Notable developments in the final guidance include the FDA’s emphasis on “single patient expanded access”, provisions and the Agency’s recommendation that manufacturers publish their expanded access programs and provide the public with specific points of contact for expanded access requests. Yet, while the Agency attempts to address manufacturer concerns regarding how negative outcomes could affect the drug approval process, manufacturers may not yet be fully ready to embrace expanded access requests, nor may they be ready to do so. Will the FDA’s announcement result in drug companies receiving increased compassionate use inquiries from physicians, and if so how can they prepare to have the processes in place to handle the requests appropriately? This one hour seminar will also address:

• Form FDA 3926- what manufacturers need to know
• Understanding the three categories for expanded access
  • Category specific requirements
  • Types of submissions permitted
• Designating a point of contact and primary responsibilities
• Impact of adverse events on submissions & approvals

Speakers:
David Farber
Partner
King & Spalding

Preeya Pinto
Partner
King & Spalding

Lisa Dwyer
Partner
King & Spalding

Contact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 | bakins@q1productions.com​