Da Hee Han, PharmD, Author at MPR - Page 2 of 364

Da Hee Han, PharmD

All articles by Da Hee Han, PharmD

FDA: Unapproved Genetic Tests Claim to Predict Drug Response

The Food and Drug Administration (FDA) issued a warning to Inova Genomics Laboratory for the illegal marketing of pharmacogenetic tests for predicting medication response to antidepressants, opioids, cancer therapy, anesthesia, and diabetes treatments. The warning letter describes how Inova’s MediMap tests are being falsely marketed to predict drug response to aid in making treatment decisions…

FDA to Review Istradefylline NDA for Parkinson Disease Again

Kyowa Hakko Kirin announced that the Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for istradefylline (KW-6002) for use as adjunctive treatment to levodopa/carbidopa in adults with Parkinson disease (PD) experiencing OFF episodes. The NDA submission was rejected in 2008 due to concerns over efficacy findings. Istradefylline is an oral…