Understanding and Adapting to New Guidance Regarding the Parameters of Conversation and Dissemination of Information Regarding Off- Label Use of Medical Devices
Anne K. Walsh
Hyman, Phelps & McNamara PC
Darren W. Alch
Vice President, General Counsel & Compliance Officer
- What the FDA Draft Guidance means for medical device promotion
- Best practices to update your salesforce training program
- Necessary adjustments to be made to your controls for your outside contracted sales team
- When, where, and how you can distribute medical publications
- Does the First Amendment still protect that right to distribute as it was deemed in WLF v. Friedman?
- How does this translate overseas?
- Managing your salesforce and FCA exposure
- What happens when your sales team instructs providers to utilize a device in a context that can lead to overbilling?
- Analyzing the consequences of Medtronic Spine and the kyphoplasty settlements
- Balancing that fine line of medical device sales and playing doctor
- Warranty issues
- What can we expect from promised FDA further guidance?