A sampling of global guidelines on the use of genomic biomarkers in drug development.
The US Food and Drug Administration established the Genomics and Targeted Therapy Group, within their Office of Clinical Pharmacology, to enable integration of genomics into the development, use and regulation of medication.
Guidelines have also been developed within the International Conference on Harmonization framework to harmonize activities among regulatory agencies in the...
Jana Grieb, European regulatory and market access legal expert at McDermott Will & Emery, explains why the healthtech and pharma industries are warming to the new EU health commissioner as he faces calls to make the MDR more “user friendly.”
While big pharma pours billions into creating new anti-aging molecules, a Belgian startup has taken a different path: combining existing safe drugs with AI precision. The early results suggest it might be onto something revolutionary.
Bristol Myers Squibb executive Doxie Jordan discusses his path to global commercial leadership and the principles guiding pharmaceutical market strategy
