Combination Product Reporting Rule Set For 2020 Enforcement
US FDA's long-delayed final rule on postmarketing safety reporting will mostly go into effect next July, though manufacturers who file reports via the Vaccine Adverse Event Reporting System have a little extra time, with their compliance date set for 31 January 2021.
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After issuing a major combination product post-market safety reporting rule at the end of 2016, US FDA released guidance to add context for companies developing the products. The agency has also extended compliance deadlines in many cases until 2019.
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