Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability

16 organizations filed 16 public comments on Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability, at the Food and Drug Administration. The comment window closed 3582d ago.

Commenters (16)

• Advanced Medical Technology Associationtrade assoc.

  1 filing · confidence 97%
• American Association for Cancer Researchtrade assoc.

  1 filing · confidence 85%
• American Association for Clinical Chemistrytrade assoc.

  1 filing · confidence 85%
• American Cancer Society Cancer Action Networktrade assoc.

  1 filing · confidence 85%
• American Clinical Laboratory Associationtrade assoc.

  1 filing · confidence 85%
• American Medical Associationtrade assoc.

  1 filing · confidence 97%
• American Medical Informatics Associationtrade assoc.

  1 filing · confidence 85%
• American Pharmacists Association (APhA)trade assoc.

  1 filing · confidence 97%
• American Society of Human Geneticstrade assoc.

  1 filing · confidence 85%
• Association for Molecular Pathologytrade assoc.

  1 filing · confidence 85%
• Foundation Medicinetrade assoc.

  1 filing · confidence 85%
• Global Alliance for Genomics and Healthtrade assoc.

  1 filing · confidence 85%
• National Society of Genetic Counselorstrade assoc.

  1 filing · confidence 85%
• Personalized Medicine Coalitiontrade assoc.

  1 filing · confidence 85%
• Pfizer Inc.unverified attribution

  1 filing · confidence 70%
• The Coalition for 21st Century Medicinetrade assoc.

  1 filing · confidence 85%