The efforts of FDA’s Office of Pharmaceutical Quality (OPQ) to standardize and streamline the CMC information in applications and how it is reviewed – initially for abbreviated new drug applications (ANDAs), and eventually for NDAs, and even biological license applications (BLAs) – is beginning to take concrete form.
The current application processes, which have been in place for decades, are largely text-based and depend heavily on electronic “papers” that have to be manually mined for information. FDA recognizes that it is an inefficient system that is prone to errors and a high degree of subjectivity and has limited knowledge management capabilities at the product, process and facility levels.
The new Knowledge-aided Assessment and Structured Application (KASA) and pharmaceutical quality/CMC (PQ/CMC) initiatives are designed to address these concerns through establishing rules for product and process risk assessment, computerizing assessments of applications, and minimizing text-based narratives.
FDA has been providing more detailed information on the structure and goals of the KASA program as it takes more concrete form. A description of the initiative was published in March (link provided below), and at the closing plenary session of the FDA/Product Quality Research Institute (PQRI) conference on “advancing product quality” held in Rockville, Maryland in April, a team of OPQ officials gave a series of back-to-back presentations and fielded a variety of questions on KASA’s progress and goals.
The session was moderated by OPQ Deputy Director Lawrence Yu. At the opening plenary session of the conference, Yu also provided an update on his office, including its KASA and PQ/CMC efforts, as part of his talk on pharmaceutical development and “the evolving regulatory landscape.”
With patient-centricity an underlying theme, the PQRI/FDA conference as a whole included tracks focused across the breadth of key concerns with which OPQ is engaged: ● Track 1 on biopharmaceutics addressed “novel approaches to improve treatment outcomes and patient safety.” ● Track 2 covered “emerging technologies and patient centricity in early drug development.” ● Track 3 encompassed “novel manufacturing technologies and challenges for the production of patient-centric drug products.”
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