FDA delays follow-on biologics guidance

The FDA will defer issuing guidance on its views about the scientific aspects of follow-on biologics pending the outcome of a workshop on the topic, Acting FDA Commissioner Lester Crawford said Wednesday. Speaking at a Senate Judiciary Committee hearing, Crawford said FDA and the Drug Information Association, a not-for-profit educational organization, will hold a joint workshop on follow-on biologics in the late summer or early fall. The agency previously planned to issue the draft guidance this summer. It has come under pressure from the Biotechnology Industry Organization to give industry an opportunity to present its views prior to drafting or releasing the document (see BioCentury, June 21, 2004). ...