Comment from Parenteral Drug Association (PDA)
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Summary: The Parenteral Drug Association (PDA), a non-profit international professional association, submitted detailed feedback on the M4Q(R2) Draft Guidance. They propose specific technical additions and clarifications regarding nitrosamine risk assessments, AI/ML technologies, primary packaging labeling, and requirements for biologics and combination products to ensure global regulatory alignment.
See attached comments from the Parenteral Drug Association