Draft Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings with Sponsors and Applicants for PDUFA Products.'' This draft guidance document is intended to provide guidance to industry on procedures that will be adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for formal meetings between the agency and sponsors or applicants concerning certain drug products.