FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: FORMAL MEETINGS BETWEEN THE FOOD AND DRUG ADMINISTRATION AND SPONSORS OR APPLICANTS OF PRESCRIPTION DRUG USER FEE ACT PRODUCTS; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Aug. 13 -- Food and Drug Administration has issued a notice called: Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Guidance for Industry; Availability.

The notice was published in the Federal Register on Aug. 13 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This guidance outlines the recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development a...