Zdrowie i gospodarka · 26/01/1999

Guidance on Amended Procedures for Advisory Panel Meetings; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance on Amended Procedures for Advisory Panel Meetings.'' The purpose of the guidance document is to establish standard operating procedures (SOP's) to be followed by the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), FDA personnel, and interested persons outside FDA in carrying out the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).