Product Evolution

In late 2020, Fresenius Medical Care North America’s (FMCNA) Renal Therapies Group announced that DELFLEX® peritoneal dialysis solutions was now available in Biofine® containers. Where medical waste remains one of the largest contributors to plastic in landfills, Fresenius offering dialysates in recyclable bags was revolutionary. However, per FDA standards, new containers for existing pharmaceuticals required the solution to be submitted with a New Drug Application (NDA).

My role in Fresenius’ NDA for the Biofine container was to update the drug label, Product Insert, and Instructions For Use per CFR Title 21 and its associated Guidance for Industry document. This process included correcting the existing label’s spelling, grammar, and layout. Below, you can see how the label evolved in during the phase one trials from the original document on the left to the corrected document on the right.

The Label

The corrections, in red, are mine and are from a presentation I created to illustrate critical issues I found within the document.

During phase two, the label took on more content and the new container size allowed for an improved layout.

Remarkably, the combined printed surface area 31.9% smaller than the phase one label.

The Product Insert

The Biofine Product Insert (PI) document provided its own challenges. As a legacy product, updates to this white paper did not go unchallenged. The document had been updated and approved prior to my starting on the project. However, much of it was written in a passive voice and some portions were reiterations of statements made elsewhere in the document. Given the packaging limitation of being able to include no more than a booklet made from a single-fold 17″ x 11″ paper, I was able to address my concerns while reformatting the required information to fit the required space.

Where the previous document was for the Biofine container, another team was working on the Safe-Lock valve system to reduce the risk of touch contamination. This product was added to the Biofine line and their existing lines, still using PVC containers. I joined that team’s efforts and finished their Product Insert (PI) document after their own technical writer took an extended leave of absence.

The Biofine NDA was approved by the FDA in October 2020.

For comparison, still published product inserts from the same company showing a writing style distinctly different from mine are available online.