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As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law Blog

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog

Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. 29, 2023) (“Basis”); NPRM at 44,603. In 2023, HHS conducted a different approach, a two-part test, to determine whether marijuana has a CAMU. 21 U.S.C. § Basis at 18; NPRM at 44,605.