Bush passes FDA reform bill
President Bush has signed legislation reforming several U.S. FDA regulatory processes and increasing its use of information technology.
The legislation, H.R. 3580, is now Public Law 100-85, having passed the Senate and the House of Representatives two weeks ago.
The law mandates that the Department of Health and Human Services establish an identifier on medical devices labels. The new also expand the services of an existing clinical trials registry data bank, by demanding it is made public via the internet.
The online database will give physicians and patients information on clinical trials and enable enrollment. Trial information will include: a summary in layman’s terms; the primary purpose; study design, type and phase; primary condition or disease being studied; intervention name and type; start and completion dates; targeted number of subjects; participant criteria; and the sponsor and contact information. All trial results will be published on the registry.
The legislation, H.R. 3580, is now Public Law 100-85, having passed the Senate and the House of Representatives two weeks ago.
The law mandates that the Department of Health and Human Services establish an identifier on medical devices labels. The new also expand the services of an existing clinical trials registry data bank, by demanding it is made public via the internet.
The online database will give physicians and patients information on clinical trials and enable enrollment. Trial information will include: a summary in layman’s terms; the primary purpose; study design, type and phase; primary condition or disease being studied; intervention name and type; start and completion dates; targeted number of subjects; participant criteria; and the sponsor and contact information. All trial results will be published on the registry.