Zdrowie i gospodarka · 19.05.1998
First Party Audit Program
The Food and Drug Administration (FDA) is announcing an industry exchange meeting to discuss with the regulated industry a new initiative being considered by the agency. The First Party Audit Program (FPAP) is intended to gather information from selected human use pharmaceutical manufacturers regarding their quality assurance measures. This information would be submitted to FDA by those firms and would substitute, in some measure, for information the agency would otherwise obtain from its direct inspectional activities. The industry exchange meeting is intended to present the broad concepts of this initiative, discuss attendant issues, and obtain feedback from all interested parties as to the merits of proceeding with the project. This meeting is cosponsored by the Center for Drug Evaluation and Research's (CDER's) Office of Compliance and the Office of the Commissioner's Industry Small Business and Community Affairs Staff.