FDA’s Peter Marks says there may be a way to reduce the regulatory burden for pancreatic islet cell treatment for diabetes. Researchers in Canada and Europe note access to therapy is limited in the US since FDA regulates islet cells as a drug while other countries regulate them as a tissue or organ.

Pink Sheet’s Drug Review Profile looks at the timeline behind the development and FDA review of CellTrans’ treatment for type 1 diabetes.

Although the CRL delayed the cell therapy’s approval by almost two years, additional CMC-related testing requested by the FDA ultimately came to be seen as a good thing by sponsor CellTrans because it provided assurance of product consistency.

FDA's review of documents and source data files to assess product efficacy and subject safety was complicated by missing and inconsistent data, the clinical reviewer said, concluding there was insufficient data monitoring during clinical studies or in preparing the documents for regulatory submission.