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Mintz | USA | 20 Nov 2023
The LDT Debate: Unpacking Public Responses to FDA’s Proposed Rule
The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as…
Duane Morris LLP | USA | 8 Nov 2023
Breaking News- FDA Pushes Back Enforcement Deadline for MoCRA Facility Registration and Product Listing Requirements to July 1, 2024
Today, FDA announced updated guidance regarding its MoCRA rollout. FDA does not intend to enforce the requirements related to cosmetic product…
Baker McKenzie | USA | 20 Sep 2023
Legal makeover guide for complying with new cosmetic regulations under MoCRA: part two
This article is the second in a series on cosmetics and delves into the good manufacturing practices (GMP) regulations that the Food and Drug Administration (FDA) plans to establish for cosmetic products. This article provides an overview of some of the GMP frameworks shared by the FDA during a listening session, as well as an overarching commentary from the industry.
Bergeson & Campbell PC | USA | 7 Sep 2023
EPA Posts Resources on Rule to Accelerate Use of PIPs
The U.S. Environmental Protection Agency announced on August 4, 2023, that it is providing resources to help biotechnology developers exercise the…
Reed Smith LLP | USA | 6 Sep 2023
SDNY Dismisses Economic Injury Class Action Based on Express OTC Preemption
Patora v. Vi-Jon, LLC, 2023 U.S. Dist. LEXIS 153421 (S.D.N.Y. Aug. 30, 2023), is a typical express preemption decision resulting in dismissal of a…
Duane Morris LLP | USA | 7 Aug 2023
FDA Issues Long-Awaited Draft Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products Under MoCRA
MoCRA’s long-awaited rollout continues as today FDA released draft guidance to assist persons submitting cosmetic product facility registrations and…
Mintz | USA | 18 Jul 2023
Those Aren’t Doritos: FTC and FDA Send Warning Letters to Companies Marketing Delta-8 Infused Munchies
The Federal Trade Commission’s (FTC) recent press release marks a continuation in government action against manufacturers of products infused with…
Bergeson & Campbell PC | USA | 31 May 2023
EPA Issues Final Rule to Accelerate Use of Plant-Incorporated Biotechnologies
On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP)…
Reed Smith LLP | USA | 12 May 2023
Ninth Circuit: Call a Spray a Spray - Butter Substitute Labeling Claims Preempted by the FDCA
We start with the usual poodle report - actually with a comment that these may be drawing to a close, as Luca is only a few points from finishing his…
Baker McKenzie | USA | 10 May 2023
FDA issues guidance on predetermined change control plans for AI/ML-enabled device software functions
The Food and Drug Administration (FDA) recently issued draft guidance for manufacturers whose medical devices use machine learning (ML) technologies to improve patient care. Through the draft guidance, the FDA intends to provide a least burdensome approach to support iterative improvements to ML-enabled device software functions through modifications, while continuing to provide a reasonable......
