Two hours. [background noises] [background noises] good morning the Senate Special committee will come to order welcome everybody. Welcome to the committees eighth hearing of the one her 18th congress about Drug Development for rare and serious diseases. As is the tradition of the committee, the aging Committee Ranking member, Ranking Member brought in this case will offer an opening statement. Thank you, senator. Thank the witnesses for coming and for all of the folks from around the country here today. There are over 7000 rare progressive and serious diseases known to man. It is estimated 95 black treatment. Yet in my time et cetera there is not been one Senate Hearing to examine promising therapies for people with rare progressive and serious diseases. The room is packed with people, patients and caregivers that live in this reality every single day. Right here, 350 patient stories from 44 states. This is long overdue. People that watch their bodies deteriorate in real time. Family
Patients with Rare Diseases. Advocates for medical ethics and a therapeutic industry professionals also testified to provide insight on the fda Clinical Trial process. This hearing before the Senate Special Agent Committee is about two hours. [background noises] [background noises] good morning the Senate Special committee will come to order welcome everybody. Welcome to the committees eighth hearing of the one her 18th congress about Drug Development for rare and serious diseases. As is the tradition of the committee, the aging Committee Ranking member, Ranking Member brought in this case will offer an opening statement. Thank you, senator. Thank the witnesses for coming and for all of the folks from around the country here today. There are over 7000 rare progressive and serious diseases known to man. It is estimated 95 black treatment. Yet in my time et cetera there is not been one Senate Hearing to examine promising therapies for people with rare progressive and serious diseases. Th
In a break with past precedent, last year's Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes.