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CCTST Grand Rounds

FDA from a Former FDAer: Secrets and Insights into Regulatory Review and Drug Development

Andrew Mulberg, MD
Vice President
Global Regulatory Affairs
Amicus Therapeutics



  1. Explain the regulatory evidentiary standards for drug development for approval of orphan drugs as non-orphan drugs.
  2. Describe the role of biomarkers and patient reported outcomes in precision medicine drug development.
  3. Identify the current gaps in registration for products in rare diseases.

Offered in conjunction with the conference Ethics of Integrating Research and Clinical Care.  Separate registration required for conference.

View Grand Rounds slides

View Grand Rounds flyer

Target audience: physicians, other health practitioners, researchers, community health advocates.

The University of Cincinnati is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The University of Cincinnati designates this live activity for a maximum of 1 AMA PRA Category 1 Credit(s)™.

Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Date & Time: 
Friday, March 24, 2017 - 12:00pm to 1:00pm
7051 UC Medical Sciences Building (MSB)
Contact Person: 
Sarah Elam
Contact Email: 
Event Category: