​Regulatory Science and Policy Positions and Documents

Subcommittee Documents

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AACR Comments to FDA Codevelopment Draft Guidance (Oct. 6, 2016) 

AACR Comments to FDA NGS Databases Draft Guidance (Oct. 6, 2016)

AACR Comments to FDA NGS Standards Draft Guidance (Oct. 6, 2016)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Comments to the FDA regard​ing its draft guidance: Framework for Regulatory Oversight of Laboratory-developed Tests (LDTs) (Feb. 2, 2015)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Comments on FDA draft guidance on companion diagnostic devices (Oct. 12, 2011)

Comments to FDA in response to the December 2010 draft guidance: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination (Feb. 14, 2011)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