This information collection supports FDA guidance covering drug and device manufacturer communications with payors, formulary committees, and similar entities (collectively referred to as payors). If a manufacturer communicates health care economic information (HCEI) for approved prescription drugs (including biological products that also meet the definition of “drug” under the Federal Food, Drug, and Cosmetic Act) and approved/cleared medical devices (collectively referred to as medical products) to payors, FDA recommends the inclusion of certain information (e.g., study design and methodology of economic analysis, limitations to an economic analysis, FDA-approved indication).
The latest form for GFI: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities Questions and Answers expires 2021-08-31 and can be found here.
Approved without change
|New collection (Request for a new OMB Control Number)||2018-06-14|