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Client Alerts 11 results
Client Alert | 3 min read | 03.27.25
MoCRA Under the Trump Era: A Look at FDA's Monitoring and Enforcement Two Months In
Despite other sweeping changes to the federal government under the Trump administration, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), passed under former President Biden, remains good law. Below, we report on recent trends in FDA’s implementation and enforcement of MoCRA in the early months of Trump’s presidency.
Client Alert | 3 min read | 12.24.24
Only Drugs Allowed: Federal Circuit Affirms Order To Delist Device Patents From the Orange Book
On December 20, 2024, the Federal Circuit affirmed a district court’s holding that five device patents had been improperly listed in the Orange Book by Teva Pharmaceuticals, Inc. as claiming a drug, and ordering that they be delisted.
Client Alert | 2 min read | 06.26.24
FDA Unveils Its “First Look” Into How It Will Enforce MoCRA
A warning letter posted by the Food and Drug Administration (FDA) on June 18, 2024 offers a first glimpse into how FDA may enforce its new regulatory scheme for products that fall within the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)’s purview. While MoCRA was enacted in December 2022 and many of its provisions became enforceable on December 29, 2023, until now, many have wondered how FDA will exercise its new enforcement powers.
Speaking Engagements 1 result
Speaking Engagement | 05.10.22
"FDA Enforcement and Regulatory Trends: What’s Ahead in 2022?," Crowell & Moring Webinar, 2022.
Blog Posts 1 result
Blog Post | 07.19.22
Crowell & Moring’s Retail & Consumer Products Law Observer