The FDA’s New Civil Penalties:How Simple Violations Could Cost You Millions
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- $10,000 a day for clinical trials information that is false, misleading or not submitted to the national registry
- One million dollars for violating a REMS requirement and up to $10 million additional in fines for continued violations after notice from the HHS secretary
- $250,000 for the first instance of disseminating false or misleading DTC ads and $500,000 for each additional violation within a three-year period after notice from the HHS secretary
And now, nearly a year later, Congress and public interest groups are putting the pressure on the agency to crack down on noncompliance and invoke its new power.
Understand these new rules, have best practices and strategies in place to comply with them and avoid potentially devastating penalties — including huge fines, bad publicity and the possibility of congressional scrutiny.
Gain the knowledge you need to allay your fears and concerns …
In a 90-minute Encore presentation, Arnold & Porter’s Vernessa Thomas Pollard and Dan Kracov will detail what you need to do to comply with the new laws to avoid being penalized, trends in the FDA’s use of civil penalties and what to expect in the near future.
Sign up your entire team to listen in and discover:
- All the facets of the new penalties and the violations that trigger them
- How the agency determines the amounts of the fines
- What aspects of the violations the FDA considers when imposing penalties
- The highest areas of risk that could cost you the highest penalties
- 10 dos and don’ts for avoiding civil penalties
- An overview of the FDA’s use of civil penalties
Register now and find out what you need to know about the FDA’s new civil penalties and how to avoid them. Plus, you’ll get an opportunity to ask your toughest questions during the Q&A session.