Remove Biochemical Assays Remove Clinical Development Remove Packaging
article thumbnail

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

Assays are tests designed to assess various properties (like potency) of chemical or biological samples. The International Society for Pharmaceutical Engineering (ISPE) took a more nuanced approach, requesting that the language be tweaked to indicate that multiple assays are often optional.