ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions

AAM's comment's for ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions Guidance for Industry

Comments from the Association for Accessible Medicines (AAM) on behalf of our member companies, regarding Docket FDA-2017-D-3101: ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Draft Guidance for Industry.

The Association for Accessible Medicines ("AAM") acknowledges the efforts of the Food and Drug Administration ("FDA" or "the Agency") on the Agency's Draft Guidance on Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions ("Draft Guidance"), which was made publicly available in June 2017. 82 Fed. Reg. 28072 (Jun. 20, 2017) (Docket No. FDA-2017-D-3101). As discussed further below, AAM has significant concerns with the Draft Guidance as it represents a fundamental departure from the GDUFA II Commitment Letter, and may unintentionally discourage ANDA sponsors from submitting a priority review request.