FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: POST-WARNING LETTER MEETINGS UNDER GENERIC DRUG USER FEE AMENDMENTS; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, June 20 -- Food and Drug Administration has issued a notice called: Post-Warning Letter Meetings Under Generic Drug User Fee Amendments; Guidance for Industry; Availability.

The notice was published in the Federal Register on June 20 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 "Post-Warning Letter Meetings Under GDUFA." This guidance provides information on the implementation of the Post-Warning Letter Meeting process for certain drug manufacturing facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations rel...