I am pleased to announce the issuance of the revised, joint Office of Generic Drugs-Office of Pharmaceutical Quality MAPP 5200.3, “Communications with Industry with respect to pre-GDUFA Year 3 Abbreviated New Drug Applications” (available on FDA’s Web site at url. It will substantially expand our communications with applicants concerning pre-GDUFA backlog, GDUFA Year 1 and GDUFA Year 2 submissions (collectively, “pre-Year 3 submissions”).
Although GDUFA requires us to act on 90% of the submissions in the pre-GDUFA backlog cohort by September 30, 2017, individual pre-Year 3 submissions lack GDUFA goal dates. This makes it hard for industry to plan product launches and conduct other business planning that affects generic drug availability. To facilitate launch planning, we will provide information concerning the review status of pre-Year 3 submissions down to the discipline and sub-quality discipline levels. This will help ensure that quality, affordable generic medicines reach the public at the earliest legally available date.
For example, OGD Regulatory Project Managers will communicate Target Action Dates, periodically update applicants and/or respond to applicant queries concerning the review status of submissions, communicate when certain major deficiencies may be forthcoming, and provide certain advance notifications of regulatory correspondences.
OGD Discipline Project Managers and OPQ Regulatory Business Process Managers will issue Informational Requests for their respective disciplines. Informational Requests are letters sent to request further information or clarification that is needed or would be helpful to allow completion of the discipline’s review. The purpose of these communications is to assure that FDA has all the information necessary to evaluate if the application is approvable or must receive a Complete Response Letter.
To facilitate meaningful communications, we are asking review staff members to refer all questions about the overall status of applications to the appropriate OGD Regulatory Project Manager.
We appreciate all of the ANDA discipline reviewers and project managers working together to expand communications with applicants. Implementing these changes will help us achieve a robust generic drug program.
Thank you,
Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
