Examining FDA's Final Guidance Documents on Medical Product Communications to Payors and Communications Consistent with Approved Labeling
12:00–1:30 PM ET
On June 12, 2018, the Food and Drug Administration finalized two critical guidance documents relating to the parameters for drug and medical device manufacturer communications. The Consistent with Approved Labeling Guidance sets forth FDA's position on truthful and non-misleading communications that present data and messaging not contained within the FDA-approved labeling but nonetheless consistent with that labeling. The Guidance on Communications with Payors, Formulary Committees and Similar Entities provides critical insights into FDA's policies relating to manufacturers' communication of FDAMA 114 and other health care economic information and analyses to payors, as well as the presentation of information to payors on investigational products and unapproved uses of approved products. In addition to the major impact of these documents on communicating important data and analyses in various settings, the new guidance documents also provide important flexibility on the communications aspects of the development and implementation of value-based payor arrangements.
Please join us for a webinar that addresses what you need to know about these new guidance documents as you assess the impact on your company's policies and practices in this area.
- New opportunities for—and important limitations on—the truthful and non-misleading communication of clinical data and analyses, such as post hoc retrospective sub-group analyses and real-world evidence studies, to healthcare practitioners and other audiences.
- Framing compliant FDAMA 114 promotional healthcare economic payor presentations based on the competent and reliable scientific evidence standard.
- New options for presenting information to payors relating to investigational products and unapproved uses of approved products.
- Implications of the new guidance documents for the negotiation and execution of risk-sharing arrangements with payors.
1.5 hours NY and CA general CLE credit (all pending)
Other jurisdictions may also be available