Presenter outlines quality‑control group to document and verify MDDs
The presenter said a small staff group will document MDDs, provide reviewer resources, resolve discrepancies, and — subject to bandwidth — determine MDDs for previously approved NDAs that lack the single‑MDD designation.
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The Presenter described a small quality‑control group responsible for documenting MDDs, supporting review staff, resolving discrepancies, and verifying MDD determinations. "This is a small group of staff that also provides resources for review staff when questions arise," the Presenter said, adding the group may also determine MDDs for NDAs approved before alignment efforts when bandwidth allows.
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