Accounting & Auditing Blog

Approval Phase of the FDA Approval Process: Continue to Utilize and Expand Relationships (Part 5)

Don't forget to check out parts one, two, three and four of this five part FDA Approval Process blog.

Our fifth and final step in this five part process is the Approval phase, which states that you must continue to utilize and expand these relationships that you have built.

Regulators – Use the partnership that you’ve created with the FDA.  Listen and use the valuable information and insight that can be provided.  Focus on any flaws of the product and be prepared to defend and embrace those aspects.  At this point you should have strong advocates from the relationships that you’ve been developing.  During this phase you’ll submit a complete NDA filing with your Risk Evaluation and Mitigation Strategies (REMS).  You’ll also be implementing the Good Review Practices (GRP).  According to the FDA’s website, a GRP is a documented best practice issued by the Center for Drug Evaluation and Research (CDER) that discusses any aspect related to the process, format, content and/or management of a product review.  During this time you’ll go through label negotiations for your end product.  Keep in mind during these discussions that the company’s priorities and the FDA’s priorities will vary greatly and its key to navigate through these discussions to arrive at a win win solution for both parties. 

Medical Scientific Community and Patient Community – Increase awareness of the benefits of your product and utilize all of your relationships that have been created to start marketing for the product’s commercialization.

Investors – Build on your prior communications to move the project forward and focus on next steps.  Build your investors’ confidence in your capabilities.  Finalize your go-to-market strategies and start to think about the next project.

To learn more about Skoda Minotti's Life Sciences & Innovation Accounting services leave a message below, or contact Marilea Campomizzi at 440-449-6800.

 

 

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