3 Ways To Rethink Regulatory Change In Personalized Medicine

By David Butcher, MasterControl

The landscape for the regulation of personalized medicine continues to evolve as the innovation in personalized medicine increases. In addition to the 20 new personalized drugs and biologics approved by the FDA in 2020, the agency also issued seven guidance documents related to precision medicine. The guidance documents include the agency’s thinking on gene therapy manufacturing and clinical development, as well as orphan drug policy for gene therapies.

As the field of personalized medicine grows and evolves, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) take steps to address regulatory oversight in the field, affected organizations should brace themselves for change and use it to their advantage.

Here are a few ways that companies in personalized medicine can approach regulatory as opportunities instead of obstacles.