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Post-Chevron FDA Rulemaking and Legal Challenges

August 27, 2024 (2 min read)

Learn best practices for advocating on behalf of your FDA-regulated clients in light of the new legal paradigm introduced by the Supreme Court’s decisions in Loper Bright and Corner Post.

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Practical Guidance Updates
Featuring the latest updates from your Practical Guidance account.

  • Draft Guidance. Announcement of the availability of a draft guidance entitled “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products.” This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of a human drug, including a biological product. The guidance describes FDA's recommendations related to the device design outputs essential for establishing and assessing drug delivery performance.
  • Draft Guidance. Announcement of the availability of a revised draft guidance entitled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.” This revised draft guidance, when finalized, will describe FDA's current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and replaces the draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” issued in June 2014.
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