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Client Alerts 16 results
Client Alert | 1 min read | 05.05.20
FDA Tightens the Rules for Antibody (Serology) Test Manufacturers
EDIT The U.S. Food and Drug Administration (FDA) walked back its policy that allowed COVID-19 antibody test kits to enter the market without agency review. In its original March 16 Final Guidance, FDA allowed commercial manufacturers to market and sell antibody test kits after internally validating their own products and notifying FDA. The Agency did not require emergency use authorization (EUA) as it did with PCR (molecular) testing, though seeking an EUA was “encouraged.”
Client Alert | 17 min read | 10.15.19
The Month in International Trade – September 2019
In this issue:
Client Alert | 15 min read | 10.04.18
The Month in International Trade – September 2018
In this issue:
Client Alert | 20 min read | 10.11.16
This Month in International Trade — September 2016
In this issue:
Client Alert | 3 min read | 09.13.16
CBP Proposes to Amend TSCA Certification Requirements
On August 29, U.S. Customs and Border Protection (CBP) published a proposal to amend the regulations regarding the requirement to file a Toxic Substances Control Act (TSCA) certification when importing chemical substances 1) in bulk form, 2) as part of mixtures, or 3) in articles containing a chemical substance or mixture. The proposed amendments include an electronic option for filing TSCA certifications, the clarification of certain definitions, and elimination of the paper-based blanket certification process.
Client Alert | 4 min read | 03.28.16
Import-Related Protection of IP Rights Strengthened in New Trade Law
On February 24, President Obama signed the Trade Facilitation and Trade Enforcement Act of 2015 (TFTE), a major customs and international trade bill designed to modernize U.S. Customs and Border Protection (CBP) procedures, promote trade facilitation, prioritize certain trade issues, and strengthen enforcement of U.S. international trade laws.
