The discussion of product review will focus on the FDA review and approval process of a NDA or BLA for a new drug or biologic product that has never before been marketed, as this is typically the most complex of FDA reviews. The FDA review process for a generic product is similar in principle but does not have the complexity of the review of a new drug or biologic product. The primary sponsor contact with FDA during product review is the regulatory affairs professional who has typically worked on the product during its development and is intimate with the contents of the submission. It is their responsibility to understand the overall review process and to effectively manage the communications between the FDA and the sponsor project team. It is also their responsibility to keep senior management of the company informed of the status of FDA's review. They are obligated to assure that information requested by FDA during the review is provided in a clear, complete, and timely fashion.
A submission of a NDA or BLA triggers a tremendous amount of work, both for the FDA and the sponsor (Fig. 7.23). The FDA has 60 days to determine if the application should be "filed" or if they will refuse to file the application. To determine if the submission should be officially filed, the FDA reviews the overall submission for all the required components, the sponsor's safety and efficacy claims in the draft package insert, the pivotal clinical studies to see if they generally support the claims, and a small number of clinical case report forms. If the FDA finds the submission lacking in required content or to be so poorly organized that it can't be reviewed, it will refuse to file the submission. At this time, the sponsor has no choice but to either address the issues or abandon the prospect of getting the product onto the commercial market in the United States.
It is typically during the review of a NDA or BLA that a sponsor and the FDA have the most frequent and intense communications that they will have during the development of the product. The number of critical activities to be accomplished within a compressed time frame require that both the agency and the sponsor have people dedicated to the review process. In order to facilitate the many interactions, both the FDA and the sponsor have a designated person who is primarily responsible for managing the liaison between the two organizations. Not only is this efficient, but it also ensures a smooth and orderly flow of information in both directions.
Once the application is accepted for filing, the various FDA review areas, including medical, statistical, pharmacology, biopharmaceutical, chemistry, and microbiology, conduct a detailed review of their sections. Typically, the FDA contacts the sponsor during the review to request additional information and/or clarification. The agency may meet with the sponsor toward the completion of their scientific reviews to discuss issues or discrepancies in interpretation of the data and advise the sponsor if an advisory committee is deemed necessary.
As the deadline for the completion of the review nears, the FDA reviewers meet to determine if the submission in its totality should be approved, including the findings from site inspections. If at this time they request the sponsor to submit a significant amount of new data, the approval of the product will be delayed. If there have been significant findings of noncompliance during any inspections, these issues need to be resolved prior to approval.
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