FDANonrulemakingFDA-2024-D-4689

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for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

RIN

—

Last modified

Jun 29, 2026

Comment window

closed 477d ago

Association for Accessible Medicines filings

Activity

Association for Accessible Medicines filed 1 comment on this docket between Apr 8, 2025 and Apr 8, 2025. 32 other organizations filed here. The comment window closed 477d ago.

What Association for Accessible Medicines filed (1)

Apr 8, 2025· Comment from Association for Accessible Medicines (AAM)· FDA-2024-D-4689-0079

Comments from the Association for Accessible Medicines (AAM): Considerations for the Use of Artificial Intelligence to Support Regulatory Decision- Making for Drug and Biological Products

View on regulations.gov →

Abstract

OPEN

View on regulations.gov →

Co-filers (32)

See everyone who commented →

Association for Accessible MedicinesTHIS ORG
1 filing · confidence 97%
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 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%