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Supply Chain Final Rules Imports

Holland & Knight LLP

Product Importers: Are You Ready for the New PFAS Reporting Requirements Under TSCA?

Holland & Knight LLP on

The U.S. Environmental Protection Agency (EPA) published a far-reaching and important final rule (Rule) on Oct. 11, 2023, requiring comprehensive reporting of per- and polyfluoroalkyl substances (PFAS) manufactured and...more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

Jones Day on

The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

ArentFox Schiff

As the (Customs and Trade) World Turns - April 2024

ArentFox Schiff on

Welcome to the April 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and...more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

Wilson Sonsini Goodrich & Rosati

First FSVP Warning Letter Issued by the FDA

In a signal to industry that the period for education and enforcement discretion related to the Foreign Supplier Verification Programs (FSVP) may be concluding, the Food and Drug Administration (FDA) recently issued its first...more

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