In 2020, personalized medicines, or precision medicines, accounted for 39% of the new drugs approved by the U.S. Food and Drug Administration (FDA), according to a report released by the Personalized Medicine Coalition (PMC) earlier this year.1 Personalized medicines have now accounted for more than a third of new drug approvals for three of the last four years.
“The pace of progress in personalized medicine continues to accelerate as the U.S. Food and Drug Administration more regularly and rapidly approves diagnostic tools and treatments that expand the frontiers of the field,” the PMC report states.
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.
As advances in personalized medicine increase, so will new regulatory oversight. Here are three ways that companies in personalized medicine can approach regulatory obstacles as opportunities instead:
To quickly get personalized, life-improving medicines to those who need them, organizations must take the necessary steps and integrate the appropriate digital tools to better adapt to a changing regulatory landscape. Embracing regulatory change can turn compliance into a competitive advantage.
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