Prescription drug and device manufacturers are only permitted to market their products for the specific uses and populations approved by the FDA. Yet, manufacturers have much more information about their products, and in some cases, their products are being used extensively in ways that are not described in their labels. Just recently, FDA released two guidances and a draft memorandum describing what manufacturers may do (and may not do) to communicate this information to healthcare providers, consumers, and payors.
Join our interactive online training course where you will learn:
- What information FDA views as “consistent with” the approved product label
- Which preapproval communications FDA views as permissible
- The types of information companies can share with payors
- Likely developments from the FDA on off-label communications
- FDA’s clarification of healthcare economic information (HCEI) and FDAMA 114