Post-Chevron FDA Rulemaking and Legal Challenges

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.

Read now »

Related Content

• Life Sciences Regulatory Enforcement Resource Kit
  Find guidance on regulatory enforcement challenges faced by your life sciences clients.

• Chevron Reversal Impact Resource Kit
  Discover analysis related to the Supreme Court’s decision to overturn four decades of deference to federal agency interpretations of ambiguous statutes. 

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

• FDA Medical Device Regulatory Activity Tracker—stay informed on new developments.  

• Draft Guidance. Announcement of the availability of a draft guidance entitled “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products.”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• Draft Guidance. Announcement of the availability of a revised draft guidance entitled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.” This revised draft guidance, when finalized, will describe FDA's current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their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 This guidance revises and replaces the draft guidance for industry entitled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” issued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.
• For Practical Guidance content on important recent trends, review easy-to-use Resource Kits on these topics:

• • Generative Artificial Intelligence (AI) Resource Kit
  • Chevron Reversal Impact Resource Kit

• Document alerts allow you to stay current on legal developments that affect your practice. Find out how to set up your document alerts. 
• Legal Developments provide the latest updates and analyses of emerging topics impacting your practice area. Visit the Legal Developments page to see the latest topics, which also include breaking legal news and related Practical Guidance content.
• Learn about the 2000+ leading attorney authors contributing to our 26 practice areas in the Practical Guidance Author Center. Interested in becoming a Practical Guidance author? Click here for details. Practical Guidance is committed to amplifying diverse voices of attorneys across all differences, including gender and race.

PRACTICAL GUIDANCE CUSTOMER EMAIL EDITION ON THE WEB

Experience results today with practical guidance, legal research, and data-driven insights—all in one place.

Experience Lexis+