Executing FDA Pre-Approval Material Review by CMK SELECT CMK SELECT CMK SELECT
CMK SELECT CMK SELECT CMK SELECT
The Challenge A pharmaceutical company with a lead compound in review to the FDA was  in the process of developing promotional and medical assets to support the product. The approval process required medical, legal, and regulatory review of all submitted materials. Internal Medical Affairs only consisted of two members supporting the product. The number of
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Executing FDA Pre-Approval Material Review

by CMK SELECT / /

The Challenge

A pharmaceutical company with a lead compound in review to the FDA was  in the process of developing promotional and medical assets to support the product. The approval process required medical, legal, and regulatory review of all submitted materials. Internal Medical Affairs only consisted of two members supporting the product. The number of assets submitted for review was overwhelming and extra support was needed to allow the medical review and approval of brand assets to be completed in a timely manner.

The Solution

A CMK Medical Affairs Specialist became part of the Medical Affairs functional team to provide reliable medical review of promotional materials for the team’s marketing asset workstream. The Specialist collaborated with the Legal and Regulatory reviewers to complete reviews of submitted materials ensuring that the medical content was accurate, appropriate, and aligned with the company’s guidelines for medical content. The CMK Medical Affairs Specialist also provided medical guidance to the brand team and external agencies, as needed.

The Results

As a result, the promotional materials receiving medical oversight ensured the brand’s marketing materials are accurate, compliant, informative, and approved in a timely manner. It was advantageous to have one medical reviewer dedicated to the promotional materials workstream to provide consistent medical guidance, and this arrangement also kept the Medical Affairs Team up to date on dynamic developments in the review space.

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CMK SELECT

Executing FDA Pre-Approval Material Review

AUTHOR: CMK SELECT

A pharmaceutical company with a lead compound in review to the FDA was  in the process of developing promotional and medical assets to support the product. The approval process required medical, legal, and regulatory review of all submitted…
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CMK SELECT

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AUTHOR: CMK SELECT

A small biopharmaceutical company is building a Medical Affairs organization and sought to understand the medical landscape and unmet medical need to create medical strategy and build an integrated medical and brand plan for a lead compound. The…
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