Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability

概要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (hereafter referred to as products). The previous guidance for industry "Formal Meetings Between the FDA and Sponsors or Applicants" published May 19, 2009, and the draft guidance for industry "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products" published March 11, 2015, have been withdrawn.