Daily Rules, Proposed Rules, and Notices of the Federal Government
FDA is announcing the availability of a draft guidance for industry entitled “End-of-Phase 2A Meetings.” This draft guidance will meet one of the performance goals agreed to under the September 27, 2007, reauthorization of the Prescription Drug User Fee Act (PDUFA IV). Under section XI of the PDUFA IV Performance Goals, Expediting Drug Development, FDA agreed to publish by the end of fiscal year 2008 a draft guidance on end-of-phase 2A meetings (see section XI.A.4 at
• Objectives of an EOP2A meeting,
• Possible topics for discussion at EOP2A meetings,
• Useful information for an EOP2A meeting package, and
• Timing of EOP2A meetings.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on end-of-phase 2A meetings. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit to the Division of Dockets Management (see
Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 and the guidance on “Formal Meetings With Sponsors and Applicants for PDUFA Products” have been approved under OMB control numbers 0910-0014 and 0910-0429, respectively.
Persons with access to the Internet may obtain the document at either