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...

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