Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases

14 organizations filed 15 public comments on Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases, at the Food and Drug Administration. The comment window closed 3582d ago.

Commenters (14)

• Advanced Medical Technology Associationtrade assoc.

  2 filings · confidence 97%
• American Association for Cancer Researchtrade assoc.

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

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

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

  1 filing · confidence 97%
• American Pharmacists Association (APhA)trade assoc.

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

  1 filing · confidence 85%
• American Society of Human Geneticstrade assoc.

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

  1 filing · confidence 85%
• Genentech Incunverified attribution

  1 filing · confidence 70%
• Leukemia & Lymphoma Societytrade 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%