Clinical Development and Regulatory Oversight of Cell and Gene‐Based Therapies from Development to Post‐Marketing

CME: 1.0

April 22, 2021
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Target Audience

This activity is intended for primary care providers, internal-medicine specialists, pediatricians, pulmonologists, cardiologists, endocrinologists, gastroenterologists, hepatologists, neurologists, neuromuscular specialists, infectious-disease specialists, obstetricians/gynecologists, rheumatologists, dermatologists, hematologists, oncologists, neonatologists, genetic counselors, social workers, psychologists, nurse practitioners, physician assistants, nurses, and pharmacists

Learning Objectives

Upon completion of this activity, participants should be better able to:

  • Summarize the key steps of development programs for gene therapies, identifying how and why some programs may differ from others
  • Explain the role of the FDA in providing regulatory oversight from development to post marketing

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