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Screening for Endocrine Activity in Water Using Commercially-available In Vitro Transactivation Bioassays
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Value Assessment in the Regulatory Context.

Kathleen L Miller1, Janet Woodcock2

  • 1Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA; Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|February 27, 2017
PubMed
Summary

New drug approvals involve rigorous benefit-risk assessments by the Center for Drug Evaluation and Research (CDER). CDER is enhancing these evaluations through patient input and increased transparency in its decision-making process.

Keywords:
FDApharmaceuticalsregulationvalue assessment

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Area of Science:

  • Pharmacoeconomics
  • Regulatory Science
  • Drug Development

Background:

  • Drug value assessments are crucial before market entry.
  • The Center for Drug Evaluation and Research (CDER) conducts clinical benefit-risk assessments for new drug approvals.
  • Efficacy quantifies drug benefits, while risk involves harm severity and probability.

Purpose of the Study:

  • To outline the framework for clinical benefit-risk assessment of novel drugs.
  • To describe CDER's initiatives for improving drug value assessments.
  • To emphasize the importance of understanding the benefit-risk trade-off for drug approval.

Main Methods:

  • Review of CDER's regulatory processes for drug approval.
  • Description of the components of benefit-risk assessment (efficacy, risk definition).
  • Overview of CDER's Patient-Focused Drug Development Initiative and transparency efforts.

Main Results:

  • Drug approval hinges on a well-understood and acceptable balance of benefits and risks.
  • CDER employs structured frameworks for benefit-risk evaluation.
  • Patient perspectives are being integrated into the regulatory process.

Conclusions:

  • Robust benefit-risk assessment is fundamental to drug approval.
  • CDER is actively working to enhance the transparency and patient-centricity of its value assessments.
  • Understanding and balancing drug benefits against risks ensures safe and effective medicines reach the market.