In response to increasing concern about drug safety, FDA has implemented several administrative and policy changes, inclduing the new Office of Pharmacoepidemiology and Statistical Science and a renewed focus on risk assessment.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.