FDA Cracks Down on Marketed Unapproved Drugs Prepare for Increased Enforcement
Product Details
Inside sources claim the FDA is planning a series of class-based enforcement actions to remove all marketed unapproved drugs within a few years.
Find out if you could be facing FDA scrutiny due to marketing of unapproved drugs and what enforcement actions could be taken against you. Then investigate the strategies you can immediately put into place to comply.
In this 90-minute Encore presentation Kurt Karst will offer you guidance on complying with the FDA's impending crackdown. He will discuss the agency's enforcement methods and actions since its June 2006 Compliance Policy Guide and offer insight on what the FDA may have planned in the near future.
Sign up your entire team to listen in and discover:
- The different types of marketed unapproved drugs that have been created by amendments to the Federal Food, Drug and Cosmetic Act
- Regarding the FDA's Marketed Unapproved Drugs Compliance Policy Guide:
- What does it mean
- How does it impact drug companies
- What elements does the FDA use to prioritize enforcement action
- Federal Register notices, warning letters, consent decrees and permanent injunctions the agency has enforced since the June 2006 Compliance Policy Guide
- Recent Congressional activity to address marketed unapproved drugs
- What future enforcement initiatives the FDA might be planning, based upon recent statements and activities
Don't miss this opportunity to discover what you need to do to be fully prepared to comply with the FDA's current enforcement of marketed unapproved drugs. You'll get a chance to ask your toughest questions during the Q&A session.