FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more
1/15/2025
/ Artificial Intelligence ,
Biologics ,
Data Management ,
Draft Guidance ,
Filing Requirements ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
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Public Comment ,
Regulatory Requirements ,
Risk Management