U.S. Food and Drug Administration (FDA) Archives - Page 15 of 42

Biden Executive Order Strengthens Buy American Government Procurement Laws

Biden Signs Executive Order Strengthening Buy American Laws

Buy American laws are a set of statutes, regulations, rules, and Executive Orders that require that the U.S. federal government require or provide preferences for purchasing goods produced in the United States. Buy American laws were created and continue to be amended with the intention of promoting economic and national security, stimulating economic growth, creating good jobs at decent wages, and supporting the U.S. manufacturing and defense industrial bases.

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By Jennifer Diaz|2022-07-07T15:10:15-04:00March 9, 2021|Best Practices, Customs Expert, Enforcement, Events, Expert, Export, Import, Import Alert, International Business, International Law, International Trade, Pre-compliance, U.S. Customs and Border Protection (CBP)|1 Comment

FDA Webinar on Human Drug Importations

On January 14, 2021, the United States Food and Drug Administration (FDA) kicked off the year with a set of Webinars for the trade community. Specifically, the Center for Drug Evaluation and Research (CDER) held its first annual Small Business and Industry Assistance (SIBA) Compliance Conference. The topics covered various areas dedicated to compliance including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance.

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By Jennifer Diaz|2022-07-07T15:08:58-04:00March 2, 2021|Best Practices, Customs Expert, Enforcement, Events, Export, FDA Issues, Import, International Business, International Law, International Trade, Supply Chain, U.S. Customs and Border Protection (CBP)|0 Comments

Building a Strong Export Compliance Plan

Co-Authored by Sharath Patil

Exporting is a Privilege, Not a Right

Over 95% of the world’s consumers are outside of the United States. Opportunities abound for U.S. companies that export. However, exporting is a privilege and not a right. U.S. exporters have an important responsibility to adhere to U.S. export control laws, including the Export Administration Regulations (“EAR”), the International Traffic in Arms Regulations (“ITAR”) the Office of Foreign Assets Control (“OFAC”) sanctions laws, and the Foreign Corrupt Practices Act (“FCPA”). Violations of export control laws carry hefty civil and criminal penalties. Exporters can pay hundreds of thousands of dollars in penalties, lose export privileges, and even be imprisoned for violations of U.S. export control laws.

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By Jennifer Diaz|2021-07-29T12:41:20-04:00February 23, 2021|Best Practices, China, China Trade War, Cuba, Customs Expert, Expert, Export, FCPA, Import, Import Alert, Iran, U.S. Bureau of Industry and Security (BIS)|7 Comments

CBP Issues WRO on Cotton, Tomato, & Downstream Products Made in Xinjiang

The United States has been increasing its efforts to combat forced labor around the world. During the Trump Administration’s final weeks, the United States not only banned the importation of Chinese Cotton, Tomatoes, among other products, but also explicitly recognized the situation in Xinjiang as a Genocide.

Importers not adequately auditing their supply chains for use of forced labor are at risk of administrative and criminal enforcement. Imported merchandise produced with forced labor is subject to the Department of Homeland Security (DHS) enforcement. Such enforcement includes U.S. Customs and Border Protection’s (CBP) right to detain, exclude, and/or seize imported goods and Homeland Security Investigation’s potential criminal investigation. China is not only the United States’ number one trading partner but also happens to be the world’s biggest forced labor violator.

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By Jennifer Diaz|2022-07-07T15:08:01-04:00February 18, 2021|Best Practices, Customs Broker, Customs Expert, Enforcement, Expert, Export, Forced Labor, Import, Import Alert, International Law, International Trade, International Travel, Pre-compliance, U.S. Customs and Border Protection (CBP)|0 Comments

Biden Administration Commits to Modernizing Regulatory Review

Co-Authored by Sharath Patil

Background on Regulatory Review

U.S. federal laws come from a wide array of sources. They are generally organized under the following order of authority: 1) the U.S. constitution, 2) statutes passed by Congress, 3) treaties ratified by Congress, 4) case law, 5) executive orders, 6) regulations, and 7) agency guidance. After Congress has provided a federal agency with a policy mandate, an agency is empowered to promulgate regulations to provide detailed and binding rules on those matters.

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By Jennifer Diaz|2021-07-29T12:44:23-04:00February 9, 2021|Export, FDA Issues, Import, International Trade, Trade Policy, U.S. Customs and Border Protection (CBP), U.S. Department of State (DOS)|0 Comments

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