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Presenter walks through sample questions and clarifies assessment vs. clarification
Summary
Using practice questions, the presenter showed which inquiries are suitable for controlled correspondence versus formal meetings and emphasized that requests that seek assessment/decisions (for example impurity limits) are assessment issues to be resolved during ANDA review.
The presenter ran through sample questions applicants commonly ask and indicated which are appropriate for controlled correspondence and which warrant a formal PDEV meeting. For example, bottom‑line questions such as whether a proposed sample preparation or analytical technique is suitable may be efficiently handled with controlled correspondence, while interrelated questions about strategy and comparative characterization can justify a formal meeting.
He gave a specific example of an unsuitable PDEV question: whether the agency agrees on a proposed limit for a particular impurity — the presenter said that is an assessment issue and the correct channel is application review. He reiterated that applicants should expect guidance in meetings but that final answers on adequacy will be determined during ANDA review.
