RAPS

Remote interactive evaluations: FDA official discusses lessons learned

To ensure the success of remote interactive evaluations (RIEs), the pharmaceutical industry should treat these evaluations with the same level of attention to detail as onsite inspections, said ...
RAPS

FDA officials impart lessons learned from quality management maturity pilots

The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or rating a manufacturers quality management ...
JD Supra

Model Behavior: FDA and EMA’s Guide to Good AI in Drug Development

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) just issued a joint statement outlining 10 “Guiding Principles” for using artificial intelligence (AI) in drug ...