Ms Mary Pendergast's submission to FDA Brown/Brownback Hearing

On 29/30 June 2010 the US FDA held a Public Hearing on how to improve the availability and processing of applications for drugs in the rare diseases (called 'orphan drugs'). This hearing was mandated by the amendment moved by Senators Brown and Brownback to the 2010 FDA Appropriations Bill.

This is the submission made by Ms Mary Pendergast, JD, President of Pendergast Consulting, who held senior positions in FDA for 33 years. She explains how Congress has already given the FDA flexibility to approve drugs for needy groups of patients, bypassing much of the paperwork, delay and expense required by current FDA management.

A written transcript of this presentation will be available, in due course, from www.regulations.gov

Category:

Science & Technology

Tags:

• FDA
• orphan drugs
• rare diseases
• multiple sclerosis
• MS
• trevor marshall
• Marshall Protocol
• autoimmunity
• autoimmune
• disease