Regulatory Science and Policy Positions and Documents

Subcommittee Documents

• AACR Comments on Priorities for the U.S. Food and Drug Administration’s Office of Minority Health and Health Equity (Feb. 28, 2020)
  
• AACR Comment to the FDA on Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration’s Office of New Drugs (Jan. 3, 2020)
  
• AACR Comments to CMS on the Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (Nov. 28, 2019)
  
• AACR Comments to the FDA on the Framework for FDA’s Real-World Evidence Program (Feb. 5, 2019)

• AACR Comments to the FDA for the Oncology Center of Excellence Listening Session Public Meeting (April 16, 2018)

• AACR Comments to FDA Codevelopment Draft Guidance (Oct. 6, 2016)

• AACR Comments to FDA NGS Databases Draft Guidance (Oct. 6, 2016)

• AACR Comments to FDA NGS Standards Draft Guidance (Oct. 6, 2016)

• AACR and AACI Comments to FDA on the Restricted Sale, Distribution, and Use of Sunlamp Products Proposed Rule (Mar. 21, 2016)

• Comments to the FDA regarding its draft guidance: Framework for Regulatory Oversight of Laboratory-developed Tests (LDTs) (Feb. 2, 2015)

• Policy Statement: Reliable and Effective Diagnostics are Keys to Accelerating Personalized Cancer Medicine and Transforming Cancer Care (Sept. 9, 2014)

• Comments to FDA regarding: Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions (July 22, 2014)

• Response to CDRH Priority Guidance (July 7, 2014)

• Comments to FDA regarding: Considerations for the Design of Early-phase Clinical Trials of Cellular and Gene Therapy Products (May 7, 2014)

• Comments to FDA regarding: Enrichment Strategies for Clinical Trials (March 12, 2013)

• Comments to FDA regarding: Pathologic Complete Response as a Surrogate End Point in Neoadjuvant Studies (July 30, 2012)

• Comments on FDA draft guidance on companion diagnostic devices (Oct. 12, 2011)

• Comments to FDA in response to the December 2010 draft guidance: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination (Feb. 14, 2011)

• Comments to the FDA regarding the co-development of investigational drugs (Sept. 7, 2010)

Subcommittee Letters

• Sign on Support Letter to Representative DeLauro (March 4, 2014)

• Letter in Support of FDA SOS Act (Dec. 7, 2013)

Other Subcommittee Policy Positions

• Regulation of Laboratory-Developed Tests (LDTs)