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FDA-Related Issues

The U.S. Food & Drug Administration’s (FDA) mission has always centered on promoting and protecting the public’s health. In recent years, the agency has demonstrated a commitment to accelerating patient access to innovative cancer treatments that are both safe and effective. The FDA has expanded its focus to incorporate the input of patients in the regulatory process, help promote robust competition that can help lower costs, and make development and review processes more efficient.

In order to achieve our mission of cures and access for all blood cancer patients, LLS actively partners with the FDA to support its efforts in the following areas:

  • Encouraging patient participation in the drug approval process
  • Streamlining expanded access to investigational therapies
  • Modernizing the clinical trial process
  • Expediting review of generic drugs and biosimilars
  • Utilizing ‘real world evidence’ to ensure FDA decisions are made with the best information available
  • Reducing ‘gaming’ by branded drug companies, including abuses of REMS systems
  • Facilitating earlier studies of therapies in the pediatric and adolescent populations.