Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

33 organizations filed 33 public comments on Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request, at the Food and Drug Administration. The comment window closed 477d ago.

Abstract

OPEN

Commenters (33)

• American Association of Pharmaceutical Scientisttrade assoc.

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

  1 filing · confidence 85%
• Animal Health Institutetrade assoc.

  1 filing · confidence 97%
• Arranta Bio MA LLCunverified attribution

  1 filing · confidence 70%
• Association for Accessible Medicinestrade assoc.

  1 filing · confidence 97%
• Association of Clinical Research Organizationstrade assoc.

  1 filing · confidence 85%
• Consumer Healthcare Products Associationtrade assoc.

  1 filing · confidence 97%
• Consumer Technology Associationtrade assoc.

  1 filing · confidence 97%
• Critical Path Institutetrade assoc.

  1 filing · confidence 85%
• eSTARHelper LLCunverified attribution

  1 filing · confidence 70%
• Florence Healthcare Site Enablement Leaguetrade assoc.

  1 filing · confidence 85%
• GATC Health Corpunverified attribution

  1 filing · confidence 70%
• GE Healthcare Incunverified attribution

  1 filing · confidence 70%
• Global Key Solutions Corp.unverified attribution

  1 filing · confidence 70%
• Health Innovation Alliancetrade assoc.

  1 filing · confidence 85%
• InSilicoTrials Technologiesunverified attribution

  1 filing · confidence 70%
• International Society for CNS Clinical Trials and Methodologytrade assoc.

  1 filing · confidence 85%
• International Society of Pharmacoepidemiologytrade assoc.

  1 filing · confidence 85%
• Invaryant Incunverified attribution

  1 filing · confidence 70%
• ISPE (International Society for Pharmaceutical Engineering)trade assoc.

  1 filing · confidence 85%
• LUNGevity Foundationtrade assoc.

  1 filing · confidence 85%
• MD Institute for Health Policytrade assoc.

  1 filing · confidence 85%
• National Alliance for Hispanic Healthtrade assoc.

  1 filing · confidence 85%
• National Association of Manufacturers (NAM)trade assoc.

  1 filing · confidence 97%
• National Health Counciltrade assoc.

  1 filing · confidence 85%
• National Institute for Innovation in Manufacturing Biopharmaceuticalstrade assoc.

  1 filing · confidence 85%
• National Multiple Sclerosis Societytrade assoc.

  1 filing · confidence 85%
• Parenteral Drug Associationtrade assoc.

  1 filing · confidence 97%
• Personalized Medicine Coalitiontrade assoc.

  1 filing · confidence 85%
• Pistoia Alliancetrade assoc.

  1 filing · confidence 85%
• Society of Quality Assurancetrade assoc.

  1 filing · confidence 85%
• The RWE Alliancetrade assoc.

  1 filing · confidence 85%
• University of Strathclydeunverified attribution

  1 filing · confidence 70%