The FDA has made a commitment in recent years to speeding up drug and device approvals. At the same time, it has ramped up its demands on life sciences companies to improve their post-marketing surveillance of new products to ensure consumer safety. Similar trends are happening in regulatory systems across the world.
This webinar explores the latest regulatory requirements in the post-marketing setting, both in the U.S. and abroad. It will provide details about some of the most recent developments in this area, including a move by the FDA in 2018 to require that companies marketing drug-device combination products report all complaints about safety to the agency.
- An explanation of the post-marketing requirements that were laid out in the Food and Drug Administration Modernization Act of 1997, as well as an overview of changes and additions that have been made since that time.
- Real-world examples of how post-marketing requirements caught some companies by surprise, and how they adapted their internal practices to be better prepared for such requirements going forward.
- A comparison of requirements for post-marketing surveillance from the FDA and key overseas regulatory bodies, including the European Medicines Agency.