The FDA Safety & Innovation Act (S. 3187), FDASIA, is signed by President Obama in July 2012. FDASIA provides for the development of effective and safe treatments for rare diseases and orphan drug development in the United States. FDASIA provides for the following :
• Acceleration of new medical treatments for patient access
• Development of Humanitarian Use Devices (medical devices) for small patient populations
• “Breakthrough Therapy” designation for drugs that show early promise in the development process
• Consultation with rare disease medical experts
• Creation of a rare pediatric disease priority review voucher incentive program.
The task of implementing FDASIA is complex and a large undertaking. FDASIA is a 140-page law that is divided into 11 separate sections, with each section addressing different aspects of the new drug and device law. To ensure that FDASIA is implemented successfully, the FDA set up a steering committee. One of the committee’s projects is to create a table that tracks…
View original post 292 more words
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....
