7/18/2023 0 Comments Amcp dossier![]() ![]() Unapproved Use Dossier: to communicate information about an unapproved use (of an approved product) for which FDA approval is being sought.Approved Product Dossier: to communicate information (clinical and economic evidence) about an approved product provided based on an unsolicited request. ![]() Unapproved Product Dossier: to communicate information about an unapproved product for which initial FDA approval is being sought.The FEC outlined three distinct dossier types that will be noted: This will be the sixth update to the Format. It is expected that these changes will align AMCP guidance more closely with FDA guidance. Unpublished data on file – at the discretion of the manufacturerĪt the October 2019 AMCP Nexus meeting, the AMCP Format Executive Committee (FEC) provided an overview of upcoming changes to the AMCP guidelines.Clinical trial information from Phase 1, Phase 2, and Phase 3 studies (peer-reviewed publications congress abstracts, posters, and presentations the company’s internal standard response letters or information).The AMCP Format v4.0 states that manufacturers may use the pre-approval submissions guidance as a template for information in response to a payor’s request for a pre-approval “dossier.” Include these elements: As new information or updated versions of previously communicated information regarding a product become available, the FDA guidance recommends providing this information to the payorĪMCP Format for Formulary Submissions Guidance.A prominent statement disclosing FDA approved, cleared, or licensed indications and a copy of the most current FDA-required labeling.Inclusively presented results (i.e., both positive and negative or null findings should be presented).For communications that include factual presentations of results from studies, a description of material aspects of study design and methodology, and disclosure of material limitations related to design, methodology, and results.Information related to the stage of product development (e.g., the status of any study in which a product or new use is being investigated, how it relates to the overall product development plan, whether a marketing application for the product or new use has been submitted to FDA, or when submission is planned).A clear statement that the product or use is not approved, cleared, or licensed, and that the safety or effectiveness of the product or use has not been established.In addition to the above information, the guidance recommends including the following in the pre-approval document. Factual presentations of results from studies, including clinical studies (i.e., no characterizations or conclusions regarding the safety or effectiveness of the unapproved product or the unapproved use).Patient utilization projections (e.g., epidemiological data projection on incidence and prevalence).The anticipated timeline for possible FDA approval, clearance, or licensure of the product or new use.Information about the indications sought. ![]() In summary, the guidance recommends providing the following unbiased, factual, accurate, and non-misleading information. The guidance provides recommendations for those communications. Payors prefer to receive information from manufacturers well in advance of a product’s approval by the FDA so that they can make timely coverage and reimbursement decisions. It also addresses key questions about the communication of information for unapproved products as well as unapproved uses of approved products. In June 2018, the United States Food and Drug Administration (US FDA) released an important guidance document – “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities–Questions and Answers.” The document addresses frequently asked questions about health care economic information for approved products. Article contributed by: Shahnaz Khan, MPH, Executive Director, Market Access and Outcomes Strategy at RTI Health Solutions FDA Guidance
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