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Panel recommends clearer communication and timeline sharing to speed DMF reviews
Summary
Panelists said lack of communication between ANDA applicants and DMF holders — especially about review goal dates and letters from the agency — commonly causes delays; they recommended sharing timelines and incorporating as much data as practicable into submissions.
Panelists repeatedly identified communication gaps as a leading cause of delays in DMF and ANDA reviews. "It would be helpful if the ANDA applicant shares their review goal dates with the DMF holder so that they can coordinate," a panelist said, noting that goal-date sharing helps DMF holders respond promptly to agency letters.
Speakers advised applicants and DMF holders to incorporate as much explanatory material as possible into submissions and to notify partners when issues arise so responses can be coordinated. "So I think that what you can communicate should be communicated, just to help the review process along," one panelist said. The recommendations were framed as practical steps to reduce common review deficiencies and speed assessments.
