• Regulatory NewsRegulatory News

    Precision Medicine: Technology, Regulations and Challenges

    • 11 March 2016
    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...
  • Feature ArticlesFeature Articles

    Precision Medicine: Technology, Regulations and Challenges

    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...
  • Legislation Looks to Overhaul Requirements for Presentation, Content of Drug Information

    A new piece of legislation introduced in both the US Senate and House of Representatives last week seeks to make changes to the statutory requirements surrounding the authorship, content, format and dissemination of information about pharmaceuticals. Background: General Drug labeling has been mostly standardized in the US since 1979, when measures to introduce uniformity were first passed. But since that time, the US Food and Drug Administration (FDA) has noted that dru...
  • New Bill Would Standardize Package Inserts

    A new bill introduced in the Senate on 22 May would require the US Food and Drug Administration (FDA) to propose new regulations regarding the Patient Medication Information (PMI) received by patients. The proposed legislation, S.3212- Cody Miller Initiative for Safer Prescriptions Act , was introduced by Sen. Kristen Gillibrand (D-NY), and deals with PMI patients receive when obtaining drug products from a physician or pharmacist. PMI commonly includes package inser...