| Health / Medical Topics |
Post Marketing Requirement
Post-marketing Requirements (PMR)/Post-marketing Commitments (PMC) related submissions not covered under annual report and supplements. These generally would be administrative type PMR/PMC related submissions, for example, non-supplement final study reports and status update reports for BLS non-reportable (non 601.70) PMCs, etc. or Non-supplemental final study reports to an IND or NDA, if labeling is not changing. Non-annual report IND amendments. (Food and Drug Administration)
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