On Thursday (September 20th), the FDA held a meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss the Agency’s plans for implementation of the Knowledge‑aided Assessment and Structured Application program (KASA).  The FDA presented to the Advisory Committee two primary goals of the KASA program.  On the one hand, it is intended to make the review of the CMC section of NDAs, ANDAs, and BLAs more efficient through standardized templates that applicants would use to document product development, manufacturing, and product quality information in the application.  The expectation is that if the CMC information is provided in a consistent format from one application to another, the reviewers will be able to quickly find and assess the information.  The second goal of KASA is to allow the Agency to capture in its own databases the information from the multitude of applications it receives and reviews.  An extensive database of such information (e.g., specifications, stability data, critical quality attributes, and critical process parameters) could be used to expand the knowledge base regarding manufacturing and product quality and, thereby, allow the FDA to more objectively assess risks to product quality and performance.  Currently, although applications follow the basic eCTD format, the information submitted is unstructured text and would have to be entered manually into a database – a prohibitively resource-intensive process.

During the meeting, the FDA acknowledged that it will take time to fully implement the KASA program.  It will require establishment of the appropriate standardized data fields from which applicants will choose, development of a computerized user interface to capture the data, and guidance and training of the industry.  Despite these challenges, the Advisory Committee members were unanimous in their support for the Agency to move ahead with this initiative.

Currently, the FDA is planning for a “soft” rollout of KASA in 2019 whereby the new structured application format will be voluntary.  One might conclude from this that, at some point, the KASA format will become mandatory.  As such, the FDA said it is working on a guidance under Section 745A of the FFDCA regarding the requirement to submit information to the FDA in an electronic format designated by the Agency.  It appears that the order of eventual rollout will be to ANDAs first, followed by NDAs, and finally to BLAs.

In addition to their solid support for KASA, the Committee provided the Agency with advice, including:

  • Ensure that the data captured by KASA can be exported for analysis by other data-analysis programs.
  • Ensure that the data fields can be updated with new selections to choose from.
  • Consider communicating the knowledge gained through KASA back to the industry.

Such a program could take some of the subjective evaluation out of the review process, which will likely be a welcome change from the industry’s perspective.