FDA Cracks Down on Marketed Unapproved Drugs Prepare for Increased Enforcement
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In the last 12 months, the FDA has issued more than 20 warning letters, published numerous enforcement announcements and entered into consent decrees of permanent injunction over marketing of unapproved drugs.
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.
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.
Order now for your entire team to listen 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