FDA released two guidance documents regarding postmarketing safety reporting requirements (PMSR) for drug/device/biologic combination products. One guidance provides clarity on how combination products need to meet the PMSR requirements under the 2016 final rule. The second guidance, on the compliance expectations, explains that FDA will delay enforcing the full PMSR requirements to allow combination product applicants sufficient time to update their reporting and recordkeeping systems and procedures (see IPQ May 10, 2018).
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