Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers." This revised draft guidance, when finalized, will provide answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs and approved/ cleared (as defined in the guidance) medical devices (collectively referred to in the guidance as approved/cleared medical products) by medical product manufacturers, packers, distributors, and their representatives (collectively referred to as firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis, carrying out their responsibilities for the selection of medical products for coverage or reimbursement (collectively referred to as payors). This revised draft guidance also provides answers to common questions about firms' dissemination of information to payors about medical products that are not yet approved/cleared for any use (collectively referred to as unapproved medical products) and firms' dissemination of information to payors about unapproved uses of approved/cleared medical products.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2016-D-1307] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers.” This revised draft guidance, when finalized, will provide answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs and approved/cleared (as defined in the guidance) medical devices (collectively referred to in the guidance as approved/cleared medical products) by medical product manufacturers, packers, distributors, and their representatives (collectively referred to as firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis, carrying out their responsibilities for the selection of medical products for coverage or reimbursement (collectively referred to as payors). This revised draft guidance also provides answers to common questions about firms' dissemination of information to payors about medical products that are not yet approved/cleared for any use (collectively referred to as unapproved medical products) and firms' dissemination of information to payors about unapproved…
Other Federal Register documents from the same docket.
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Guidance for Industry; Availability
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Draft Guidance for Industry and Review Staff; Availability
Citation: 91 FR 33181
