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1/23/20
AMCP Format v4.1: New Guidance on Evidence Requirements for Unapproved Products and Unapproved Uses
Webinar Recorded on Jan. 23, 2020
Since 2000, the AMCP Format for Formulary Submissions has served as the gold standard for providing industry with guidance on the communication of medical product information to healthcare decision makers for the purpose of formulary, coverage, and reimbursement decision making. In its 6th revision, the AMCP Format was updated to Version 4.1 and published in December 2019. Version 4.1 provides new guidance on the two-way communication between industry and payers regarding evidence and information about unapproved products and unapproved uses of approved products for which FDA approval is being sought. The