Biotechnology holds great promise for American patients.
The United States biotech drug industry has estimated that the proposed changes will cut drug development time by months, reduce the required paperwork by thousands of pages, and save the companies millions of dollars. None of the proposed changes will diminish the safety and effectiveness of the industry's products. Firms developing and manufacturing these products will be spared the cost of preparing ELAs, some of which may be lengthy and elaborate. FDA will save review time. The agency will monitor companies' compliance with the requirement that they release only lots that have been tested and found to be acceptable.