The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. This guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
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Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled ``Compliance Policy for Combination Produc...
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83 FR 12259
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“Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability,” thefederalregister.org (March 21, 2018), https://thefederalregister.org/documents/2018-05688/immediately-in-effect-guidance-for-industry-compliance-policy-for-combination-product-postmarketing-safety-reporting-ava.