Co-Authored by Denise Calle.
On March 26, 2021, Food and Drug Administration (FDA) published the Federal Register Notice, “Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing the OTC Monograph Drug user fee program fee rates for FY 2021. This is the first year FDA has expanded user fees to OTC Drug Manufacturers and submitters of OTC monograph order requests.
Co-Authored by Sharath Patil
COVID-19’s Impact on the Global Economy
The COVID-19 pandemic has had systemic implications for nearly every facet of our lives and society. The world of international trade is certainly no exception. Businesses and governments alike have had to figure out how to continue import and export operations while accounting for the risks present in the current trading climate. Challenges that importers and exporters have faced include: 1) dramatic demand spikes for certain goods, 2) equally dramatic crashes in demand for other goods, 3) significant back-ups of inflowing shipments at key ports, 4) an increase in trade restrictions and other barriers to trade, and 5) contractions in trade volumes, just to name a few.
Co-Authored by Denise Calle
A year into the COVID-19 pandemic, the U.S. Environmental Protection Agency (EPA) and The Food and Drug Administration (FDA) are in full enforcement mode carefully monitoring novel products claiming to treat, mitigate, or “kill” COVID-19. Compliance advisories issued at the beginning of the pandemic are now being replaced with enforcement advisories. Manufacturers, importers, distributors, and others engaged in the production or sale of products claiming to mitigate or “kill” COVID-19 should be more cautious than ever when developing product claims for both product labels and marketing material or alternatively, confirm products comply with the numerous regulations governing COVID-19 cleaning products.
Background on EO 13959
On November 12, 2020, President Trump issued Executive Order 13959 (“EO 13959”), Addressing the Threat from Securities Investments that Finance Communist Chinese Military Companies. EO 13959 prohibits U.S. investors from purchasing or investing in securities of companies identified by the U.S. government as Communist Chinese military companies (“CCMCs”), a designation determined by the U.S. Department of Defense and the U.S. Department of the Treasury.
Since former President Trump signed EO 13959, the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) has issued clarifying guidance and general licenses on this matter.