Become a member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Sheraton Boston Hotel

Aug 14, 2017 7:30 AM - Aug 17, 2017 5:00 PM

39 Dalton Street, , Boston, MA 02119 , USA

Regulatory Affairs: The IND, NDA, and Postmarketing

Back to Agenda

Session 12: Special Regulatory Considerations for Development

Session Chair(s)

Elliott Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

Special Protocol Assessment
Special Development Pathways

Subpart E (expedited drug development)
Subpart H (accelerated approval)
Fast track
New pathways under FDASIA

Breakthrough therapy
Qualified infectious disease product

Orphan Products

Have an account?