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FDA – Postmarketing Safety Reporting for Combination Products

by chuck_ltd | 24 Mar, 2018 | CHCUK News & Articles, Digital Health Technology, FDA Guidance

This DRAFT guidance addresses how to comply with the final rule on postmarketing safety  reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the “combination product PMSR final rule,”...

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