Related Experiment Video

Updated: Sep 20, 2025

Cell Population Analyses During Skin Carcinogenesis
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Cell Population Analyses During Skin Carcinogenesis

Published on: August 21, 2013

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Impact of an evolving regulatory landscape on skin cancer drug development in the U.S

David M Miller1, Sophia Z Shalhout, Denise Casey

  • 1Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts, USA. dmiller4@mgh.harvard.edu.

Dermatology Online Journal
|June 7, 2022
PubMed
Abstract

Insights

The U.S. Food and Drug Administration (FDA) approved 130 skin cancer drug advancements since 1949. Regulatory frameworks have evolved alongside therapeutic landscapes to ensure safe and effective treatments.

Area of Science:

  • Oncology
  • Dermatology
  • Regulatory Science

Background:

  • Significant increase in FDA-approved skin cancer medications in the last decade.
  • Accelerated growth observed in the past five years.

Purpose of the Study:

  • Evaluate the impact of the evolving U.S. regulatory framework on drug development for skin cancer.
  • Understand current trends and regulatory considerations in skin cancer drug approvals.

Main Methods:

  • Review of publicly available regulatory documents.
  • Inclusion of all systemic medications with a labeled indication for skin cancer.

Main Results:

  • Identified 130 FDA approvals for skin cancer since 1949.
  • Approvals included unique indications, usages, formulations, or dosage changes.

Conclusions:

  • The therapeutic landscape for skin cancer has dramatically changed since 1949.
  • Regulatory medicine has evolved over 70 years to ensure safe and effective treatments for diverse patient populations.
  • Limited publicly available data exists from the mid-to-late 20th century.

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