Combo-Product Sponsors Gain Some Favored Changes In Final Post-Market Reporting Rule

US FDA’s final rule includes several clarifications about its scope and definitions, and includes some additional reporting requirements.

New Rules

US FDA's final rule on post-market reporting requirements for combination products is likely to be a welcome addition for industry.

The final rule, published Dec. 20, clarifies its scope, aims to minimize duplicative reporting, clarifies the definitions of certain terms and includes additional reporting requirements to address specific safety concerns...

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