Monday, October 13, 1997
The reform provisions
Summary of the general provisions and the drugs and biologics provisions of S. 830 and H.R. 1411. Provisions mentioned below are essentially the same in both bills, unless otherwise noted.
For the first time, Congress has mandated a mission statement for FDA, requiring the agency to:
- Protect the public health by ensuring that the products it regulates meet the appropriate FDA regulatory standards.
- Promptly and efficiently review clinical research and take appropriate action on the marketing of regulated products in a manner that does not unduly impede innovation or product availability.
- Participate with other countries to reduce regulatory burdens, harmonize regulatory requirements, and achieve reciprocal arrangements.