21st Century Diagnostics—The Foundation of Personalized Medicine
Update Magazine | Winter 2025
21st Century Diagnostics—The Foundation of Personalized Medicine
From Secret Tests to Therapy Trials: MDMA’s Long Road to Legitimacy
Compliance Challenges for Clinical Research Sites
The Complex World of Legal Bans on Meat-Sounding Names and Innovative Technologies
TCEM and NAMs: An Innovation Superhighway for Drug Development
Battling Healthcare Misinformation Through Personal Agency
FDA Announces Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes
2023 Year in Review—Canada’s Top 10 Drug and Medical Device Regulatory/Legal Issues
Some Appeal-Endangering Nuances of the Federal “Separate Document” Rule
Advancing 21st Century Regulatory Science via AI and HI
Legal and Ethical Considerations for Offering Clinical Trial Recruitment Payments and Enrollment Incentives
“Modernized” Food Manufacturing Enforcement: Trends in FDA Warning Letters
FDA Law and the Psychedelic Renaissance
Letter to the Editor: FDA Citizen Petition Seeks Historical Reckoning to Require the Labeling of Gluten on All Food Packages in the United States
<i>Chevron</i> Deference on the Brink: Small Fish May Mean Big Changes For FDA
Leqembi and the Accelerated Approval Pathway
The Curious Case of Aspartame: How the Same Evidence Can Yield Seemingly Different Conclusions
Tech Support: FDA’s Evolving Regulatory Plan for Drug- and Device-Enabling Software
Risk Sharing Agreements in Brazil
Implementing MoCRA: FDA Releases New Draft Guidances on Insanitary Conditions for Tattoo Ink and Cosmetic Product Registration & Listing
Food Labeling Regulation An Overview from Brazil and Latin America
The Accelerated Approval Program: Desiderata for a Proper Solution to the Untimely Completion of Confirmatory Trials
Regulatory Innovation: Where You Stand Depends on Where You Sit
The Grocer Will Fill Your Order Now: Modernizing Online Food Shopping Becomes a Priority for Federal Agencies
FDA’s Adoption of NSF/ANSI 455-3 National GMP Cosmetic Standard Under MoCRA Could Model World Class Example of Public–Private Partnership in a Once-a-Century Opportunity
Lacks v. Thermo Fisher Scientific Inc.—An Extraordinary Event from More than 70 Years Ago That Led to a Lawsuit, Resulting in a Settlement
<i>Ferrari v. Vitamin Shoppe</i>: A Favorable Ruling for a Manufacturer Facing a Challenge to Its Dietary Supplement Structure/Function Claims
FDA Review of New Tobacco Products: A Public Health Narrative
Suggestions for Improvement of FDA Review of New Tobacco Products
Reality-Based Healthcare Reform
Advancing the Transition to Computer Software Assurance: Responding to the FDA Draft Guidance for Production and Quality System Software
Juul Labs, Inc. v. FDA: A FOIA Twist on the Challenge to FDA’s Marketing Denial Order
Food and Beverage Container Labeling and Allergen Management: Protecting Consumer Health
Alternative Proteins: Navigating the Maze of U.S. Federal and State Meat Labeling Requirements
2022 Year in Review—Top 10 Food and Agribusiness Regulatory and Legal Issues in Canada
Important Recent Updates to DOJ Policy on Voluntary Self-Disclosure and Corporate Compliance Programs
Regulating Contrast Agents as Drugs: What’s Next for FDA?
Product Testing, Questionable Science, and the Smallest, Big Developments in Consumer Product Litigation
FTC and NAD Remind Industry of Their Authority Over All Health Product Advertising (Including Rx)
FDA Amends Final Ruling for Yogurt Standard of Identity
MoCRA Is Here—Now What? Unpacking Litigation and Regulatory Risk for Cosmetics Brands Following MoCRA’s Enactment
An Overview of Food and Drug Law Practices, 2023 Update
