Evidentiary standards for validation of multifactorial algorithms in Software as a Medical Device (SaMD) diagnostic and predictive signatures.

From Aducanumab to Tofersen, a tale of clinical development and regulatory discussions based on the power of surrogate endpoints. Two years ago1, on June 7, 2021, the FDA announced the approval of the Biogen therapy aducanumab for the treatment of Alzheimer’s disease.

What does the FDA expect in 2023 for the submission of pharmacogenomic data as part of INDs or NDAs? In 2023, DNA chips have been replaced by DNA and RNA sequencing. In 2023, drug metabolizing enzyme pharmacogenomics now coexist with pharmacogenomic biomarkers across clinical areas, diseases, therapies and platforms.