FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PRESCRIPTION DRUG USER FEE ACT VII; INDEPENDENT ASSESSMENT OF COMMUNICATION THROUGH PRODUCT QUALITY INFORMATION REQUESTS DURING APPLICATION REVIEW; FINAL REPORT; AVAILABILITY; REQUEST FOR COMMENTS

WASHINGTON, May 9 -- Food and Drug Administration has issued a notice called: Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments.

The notice was published in the Federal Register on May 9 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 document entitled "Product Quality Information Request Communications Assessment: Final Report." This report fulfills a commitment under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA) to assess communic...