FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ABBREVIATED NEW DRUG APPLICATIONS: PRE-SUBMISSION FACILITY CORRESPONDENCE RELATED TO PRIORITIZED GENERIC DRUG SUBMISSIONS; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, June 16 -- Food and Drug Administration has issued a notice called: Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Guidance for Industry; Availability.

The notice was published in the Federal Register on June 16 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 entitled "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions." This guidance describes the facility information to be submitted in a pre-submission facility correspondence (PFC) and how FDA w...