Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges Public Workshop

摘要

The Food and Drug Administration (FDA) is announcing a public workshop to discuss innovative systems for delivery of drugs and biologics. The purpose of this workshop is to serve as a forum for the academic and clinical communities, industry, consumer and patient advocacy groups, and FDA to discuss the latest scientific and clinical developments for these products, as well as any regulatory concerns and challenges. FDA hopes to facilitate the development of new technology by addressing and clarifying regulatory uncertainty and by increasing the predictability of product development. This project is a part of the Commissioner of the Food and Drug Administration's initiative entitled "Improving Innovation in Medical Technology: Beyond 2002." For reference, the white paper describing the entire initiative is available at http://www.fda.gov/bbs/topics/NEWS/2003/NEW00867.html. The input received at the workshop and from written comments will be considered in drafting guidance or other information for industry. Date and Time: The public workshop will be held on July 8, 2003, from 8 a.m. to 5:30 p.m. Addresses: The public workshop will be held at the Bethesda Marriott, 5151 Pooks Hill Rd.