Drug Development Technologies (DDTs) are methods, materials, or measures that assist in drug development and Regulatory review, as stated in the 21st Century Cures Law. These include biomarkers, clinical outcome evaluations, and other metrics. The Food and Drug Administration (FDA) has created qualification programs for biomarkers, clinical outcome evaluations, and animal models for use in accordance with the Animal Rule to support DDT development activities.
The Center for Drug Evaluation and Research (CDER) has recently launched two (2) quality management pilot programs for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). The purpose of the pilot programs is to gain insight from the third-party assessments of the manufacturer’s quality management system (QMS) and enhance the future development of the FDA rating system. It helps to characterize quality management maturity (QMM), which would allow a cross-sectional comparison of manufacturers.