Background

A major manufacturer of intravenous (IV) pharmaceuticals was experiencing product leakage issues with its IV bags. The company’s quality and engineering teams identified a solution involving a change to the resin ratio used in the bags to improve strength and eliminate leaks. However, due to unclear FDA guidance documents, the regulatory team was uncertain about the appropriate submission pathway and was preparing a time-consuming Prior Approval Supplement (PAS).

RCA Approach

Regulatory Compliance Associates® Inc. (RCA) was brought in to assess the proposed corrective action and determine the optimal regulatory strategy. RCA’s consultant reviewed the changes and confirmed that the improvement came from adjusting the ratio of existing resins—without introducing any new materials. Based on this analysis, RCA recommended submitting a Changes Being Effected in 30 Days (CBE-30) supplement rather than a PAS, significantly reducing the regulatory timeline.

Result

After consulting with the FDA and confirming agreement with the strategy, the manufacturer submitted a CBE-30. This approach enabled the company to swiftly resolve product complaints, avoid disruptions in supply, and maintain product revenue—without the delays associated with a PAS submission.