clarksonhockey
Nov 2, 1:49 AM
$CAPR Yes, companies receive key milestones and early signals during the review process, though the final formal decision is typically communicated just days or hours before the official PDUFA date.
Key Checkpoints and Early Indicators
• Mid-Cycle and Late-Cycle Communications:
The FDA holds scheduled checkpoints with drug sponsors (around month 5–6 for standard reviews or month 2–3 for priority reviews) to discuss the status of the application, major review issues, and potential labeling or safety questions.
• Post-Marketing Requirements (PMRs) and Labeling Discussions:
Under PDUFA performance goals, the FDA communicates draft labeling and anticipated post-marketing studies (such as accelerated approval confirmatory trials) weeks in advance—
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