FDA publishes Draft Guidance for Industry: Requests for Reconsideration at the Division Level Under GDUFA
On October 12, 2017, the U.S. Food and Drug Administration (FDA) published the draft guidance for industry entitled “Requests for Reconsideration at the Division Level Under GDUFA.” This draft guidance provides recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and applicants of abbreviated new drug applications (ANDAs) who wish to request reconsideration within the review discipline at the division level or original signatory authority. This guidance does not describe the formal dispute resolution procedures for resolving disputes that cannot be resolved through the request for reconsideration process at the division level, nor does it describe the procedures for resolving administrative matters, such as disputes regarding user fee assessments.
FDA is issuing this draft guidance to assist ANDA applicants who would like to request reconsideration as defined in the Generic Drug User Fee Amendments Reauthorization (GDUFA II) Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter).
To comment on the draft guidance, please visit the public docket, FDA-2017-D-5868.
Direct link to the draft guidance:
Drugs/ GuidanceComplianceRegulatoryIn formation/Guidances/UCM579746. pdf