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.
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Industry concerns they won’t meet a deadline from the FDA to comply with a combination products safety reporting requirement has led the agency to again push back a couple of implementation deadlines by a year.
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.
After major post-market safety reporting rule in 2016, guidance adds context for companies developing combination products. FDA also extends compliance deadlines in many cases until 2019.