Navigating Regulations and Compliance in Pharmacogenomics Business Operations

Pharmacogenomics regulations and compliance are pivotal in precision medicine. Approximately 90% of pharmacogenomics tests in the U.S. are non-FDA-approved laboratory-developed tests (LDTs)1. This underscores the necessity of regulations and compliance in pharmacogenomics to guarantee safe and effective treatments. For businesses in this sector, grasping pharmacogenomics regulations is critical. It enables them to navigate the intricate regulatory terrain and uphold pharmacogenomics compliance. Let's discuss Regulations and Compliance in Pharmacogenomics.

Regulations and compliance in pharmacogenomics are essential for reducing adverse drug reactions. Patients undergoing preemptive pharmacogenomic testing face a 33% lower risk of adverse drug reactions (ADRs) compared to those receiving standard care1. This highlights the critical role of pharmacogenomics compliance in patient care. The FDA has listed 261 drugs on the Table of Pharmaco...