Home » FDA Civil Monetary Penalties Increase Across the Board to Keep Pace with Inflation
FDA Civil Monetary Penalties Increase Across the Board to Keep Pace with Inflation
February 8, 2017
The FDA’s civil monetary penalties are increasing to adjust for inflation at under 2 percent.
Penalties for violating requirements for post-marketing studies, clinical trials, labeling or Risk Evaluation and Mitigation Strategies increased to nearly $290,000. The same penalty also applies to REMS violations that continue in the 30 days after receiving a written notice.
False or misleading direct-to-consumer advertising will also incur fines of almost $290,000, with subsequent violations in a three-year period drawing penalties of more than $578,000. Meanwhile, the penalty for failure to follow an order to recall a biologic increased to more than $219,000 per day.
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