Zdrowie i gospodarka · 22/02/2000
Food and Drug Administration/Industry Exchange Workshop on Scale- Up and Postapproval Changes (SUPAC), Supplements, and Other Postapproval Changes; Public Workshop
The Food and Drug Administration (FDA), Office of the Commissioner, Office of Regulatory Affairs, Center for Drug Evaluation and Research, and the Central Region Small Business Office, and the Northeast Region Small Business Office, in cooperation with the International Society for Pharmaceutical Engineering (ISPE) is announcing the following workshops: FDA/Industry Exchange Workshops on Scale-Up and Postapproval Changes (SUPAC), Supplements, and Other Postapproval Changes. The workshops are intended to review the scientific, regulatory, and quality basis of SUPAC; discuss current issues; and provide attendees with information on the impact of the SUPAC guidances that have been finalized, as well as future agency efforts in this area. Date and Time: See Table 1 following the "Location" section of this document. Location: See Table 1 below.