Final Rule for ACNU Arrives in Time for End of Year but Not Much New to...
By Deborah L. Livornese —As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an...
View ArticleWhat’s in a Claim? The Federal Circuit Rules on Orange Book Patent Listings
By Sara W. Koblitz —Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents...
View ArticleFDA Inspections: Lesson 1 – Interviewing Employees
By Anne K. Walsh & Paul M. Hyman & Douglas B. Farquhar —This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples,...
View ArticleFDA Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary...
By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J. Sasinowski —On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and...
View ArticleTo Be or Coco-Not To Be: That’s One Question Answered in FDA’s Final Guidance...
By Sophia R. Gaulkin & Riëtte van Laack —On January 6, 2025, FDA released two final guidance documents on food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen...
View ArticleAs 2024 Closed, FDA Issued a Proposed Rule on Asbestos Testing;...
By Riëtte van Laack —A little over two years ago, the Modernization of Cosmetic Regulation Act (MoCRA) was (at long last) enacted. The passing of the law which, among other things, amended the Federal...
View ArticleIs FDA Man’s Best Friend’s Best Friend?
By Charles D. Snow & Sara W. Koblitz —On January 7, 2025, FDA announced that back on November 12, 2024, the Center for Veterinary Medicine (“CVM”) issued Warning Letters to six online retailers...
View ArticleHPM Grows Its Ranks of Directors, Counsel, and Associates as it begins its...
Hyman, Phelps & McNamara PC, (HPM), which will mark its 45th Anniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the...
View ArticleFDA Recommends Disclosure of Plant Source in Draft Guidance on Labeling...
By Sophia R. Gaulkin & Riëtte van Laack —Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here, here, and...
View ArticleSIUU-SIUU-Sudio: FDA Finalizes Guidance on SIUU and Distribution of Off Label...
By Jeffrey N. Wasserstein & Dara Katcher Levy —Who among us, upon reading FDA’s draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for...
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