In a Westlaw Today article, life sciences regulatory & compliance partners Kellie Combs and Joshua Oyster, life sciences regulatory & compliance counsel Sarah Blankstein and associate Jessica Band examined the Food and Drug Administration's new draft guidance on the regulation of drug sponsors' software relating to their prescription drugs or biological drug products.
The authors summarize key principles from the FDA guidance, highlighting some departures from FDA’s proposed framework from 2018, as well as implications for drug sponsors and software developers.
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