Federal Register #2026-11060

FDA Issues Revised Draft Guidance on Manufacturer Communications With Payors

This notice announces the release of revised draft guidance by the Food and Drug Administration (FDA) regarding communications between drug and device manufacturers and payors. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Purpose: - Provides regulatory guidance for manufacturers, packers, and distributors of approved prescription drugs and medical devices - Clarifies how health care economic information (HCEI) can be communicated to payors, formulary committees, and similar entities - Addresses sharing of information about unapproved products and unapproved uses of approved or cleared products - OEMs and Vendors: - No specific OEMs or vendors are named in this notice - Products/Services Requested: - No products or services are being procured; this is a regulatory guidance document - Unique/Notable Requirements: - Seeks public comment on the draft guidance - Focuses on regulatory compliance and communication standards for industry stakeholders

Description

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers."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 guidance provides answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs and approved/cleared medical devices by manufacturers to payors and similar entities responsible for medical product selection and reimbursement. It also addresses dissemination of information about unapproved medical products and unapproved uses of approved/cleared products. Comments on the draft guidance are due by August 3, 2026.

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