Reporting Analytical Data for Regulatory Submissions: A CRO Perspective on Implementing the BP4NTA Study Reporting Tool in the Healthcare Industry

Abstract

Analytical data packages are an essential part of the CMC (Chemistry and Manufacturing Control) section of US FDA (United States Food and Drug Administration) NDA (new drug application) submissions for pharmaceuticals and biologics. In many cases, the biocompatibility assessment for medical devices also requires analytical testing to be performed and reported. Based on the quality of the data presented, the regulatory review team makes an informed decision about the safety of the drug product or the medical device. If the submission is incomplete or does not support the safety assessment of the product, additional data may be required, which often delays product approval. Study sponsors must decide between optimizing the amount and quality of the data in the filing packages to save costs upfront, which may delay the approval process versus taking the more conservative approach of providing detailed information, investing more upfront, and minimizing the risk of delays.