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FDA and Its Role in Drug Development

Richard Pazdur1

  • 1Oncology Center of Excellence, U.S. Food & Drug Administration, Silver Spring, Maryland.

Journal of the Advanced Practitioner in Oncology
|June 4, 2021
PubMed

Insights

Dr. Richard Pazdur discussed updates in oncology drug development and FDA approval pathways. Advanced practitioners

Area of Science:

  • Oncology
  • Drug Development
  • Regulatory Affairs

Background:

  • The Food and Drug Administration (FDA) Oncology Center of Excellence plays a crucial role in advancing cancer treatments.
  • The landscape of oncology drug development is constantly evolving.
  • The COVID-19 pandemic has significantly impacted healthcare and clinical research.

Purpose of the Study:

  • To provide insights into recent modifications in oncology drug development.
  • To clarify the current FDA drug approval process.
  • To examine the evolving role of advanced practitioners in clinical trials.
  • To discuss the impact of the COVID-19 pandemic on oncology research and practice.

Main Methods:

  • Presentation by Dr. Richard Pazdur, Director of the FDA Oncology Center of Excellence, at JADPRO Live 2020.
  • Discussion of regulatory changes and clinical trial execution.
  • Analysis of pandemic-related adaptations in oncology.

Main Results:

  • Key updates on oncology drug development and FDA approval processes were shared.
  • The integral role of advanced practitioners in clinical trial execution was highlighted.
  • Significant changes and adaptations driven by the COVID-19 pandemic were detailed.

Conclusions:

  • The FDA remains committed to optimizing oncology drug development and approval.
  • Advanced practitioners are essential for efficient clinical trial conduct.
  • The oncology field has demonstrated resilience and adaptability in response to the pandemic.

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