In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more
1/22/2025
/ Artificial Intelligence ,
Biologics ,
Data Privacy ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management
The FDA has just issued a Guidance on what it considers to be appropriate Current Good Manufacturing Practices (CGMPs) for Responding to COVID-19 infections in employees in drug and biological manufacturing facilities.
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FDA has just published a new Guidance that will allow for the suspension of reporting of certain adverse event reports while the COVID-19 pandemic continues. This Guidance takes effect immediately and applies to postmarketing...more