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Forum points attendees to GDUFA 3 resources; Dr. Zink introduced as next presenter
Summary
The presenter listed guidance documents and a recorded presentation covering changes implemented with GDUFA 3 and introduced Dr. Zink of the Office of Bioequivalence as the next speaker.
At the end of the session the presenter pointed attendees to reference materials including published guidances and a previously recorded presentation on changes implemented with GDUFA 3: “The guidances are listed here. Generic drug user fee authorization or commitment letter that, identifies what we've committed to do as far as, deadlines are concerned. The guidance for covered product authorization.”
She then introduced the next speaker: “I now welcome Doctor. Zink from the Office of Bioequivalent.” The presenter did not read Dr. Zink's title beyond the office name; the transcript records the introduction but not Dr. Zink's remarks in this excerpt.
