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Presubmission Accelerated Non-Launch Material
Promotional materials intended to be used after the 120 day post-approval period that are submitted to FDA prior to dissemination/publication as required by 21 CFR 314.550 and 601.45. (Food and Drug Administration)
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Promotional materials intended to be used in the first 120 days after approval that are submitted to FDA prior to dissemination/publication as…
A process that fills a dosage unit with a pressurized liquid, which is not performed under sterile conditions.
Flexible tubing designed to withstand high pressure.
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Death of tissue due to external pressure.
A device designed to monitor or display a pressure reading.
