Docket Management
Docket: 01N-0450 - Public Meeting on the Prescription Drug User Fee Act (PDUFA)
Registration Number: EAPE -32

Accepted - Volume 1

Registration for Public Meeting on the Prescription Drug User Fee Act (PDUFA)
Name Dr. Christopher Milne
Organization Tufts Center for the Study of Drug Development

1. Brief statement of the general nature of the views you wish to present. The Center will present data that addresses program question #1 on the impact of PDUFA I & II on FDA's mission, and also present data on the public health impacts and increased FDA workload resulting from the implementation of the pediatric and fast track provisions of PDUFA II/FDAMA.
2. The names and addresses of all persons who will participate in the presentation. Dr. Christopher-Paul Milne Asst. Dir., Tufts Ctr. for the Study of Drug Development Tufts University 192 South Street, Suite 550 Boston, Massachusetts 02111 USA
3. Approximate time that you request to make your presentation. Powerpoint presentation requiring 15-20 minutes.
4. Special Accommodations required? Please specify. None.



EAPE -32