BioCentury
ARTICLE | Regulation

FDA ponders loosening ELA process

July 17, 1995 7:00 AM UTC

WASHINGTON - The FDA announced that it is considering eliminating establishment licenses (ELAs) for well-characterized biotechnology products. It also announced the availiabiity of a Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products.

The agency plans to hold a scientific conference in the fall to discuss issues related to ELAs for biological products. ...