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 
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
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
For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of
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Biden Administration Commits to Modernizing Regulatory Review
February 9, 2021
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