Hot Topics in International Trade USMCA facilitation
Hot Topics in International Trade - Managed Services and FTZs
US-China International Trade Law: What You Need to Know Now
4 Key Takeaways | Solar Industry & Chinese Tariff Update
Hot Topics in International Trade-De Minimis With Bob Brewer, and Robert Stein, VP Braumiller Consulting
Hot Topics in International Trade. BLG VP Marketing Bob Brewer sits down with Robert Stein, VP Braumiller Consulting Group and discusses the recent bridge collapse via the Dali at the Francis Scott Key
Wiley's 10 Key Trade Developments: Evasion and Circumvention
Hot Topics in International Trade- The Importer of Record
10 Key Trade Developments: Trade Remedy Cases
Hot Topics in International Trade-The Mod Act
Episode 309 -- Alex Cotoia on Compliance with the Uyghur Forced Labor Prevention Act
Episode 308 -- Gabrielle Griffith, Director BPE Global, on Trade Compliance
10 Key Trade Developments: China
Hot Topics in International Trade
Hot Topics in international trade
Hot Topics in International Trade- A Year in Review (Quickly) with Braumiller Law Group Attorney Brandon French
Hot Topics in International Trade A Year in Review (Quickly)
Prior Disclosure
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug...more
On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more
On Friday, January 5, 2024, in a major policy shift, the U.S. Food & Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s plan to purchase medicines in bulk for its Medicaid programs,...more
On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval. Generally, there are three pathways to importing a prescription drug into the United...more
The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...more
Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing its policy regarding requests for the importation of unapproved finished...more
The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential methanol content. The press...more
On September 25, 2020, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)....more
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
On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more
This article discusses the global developments for the registration of cannabis and cannabis-related trademarks in the United States, Canada, Mexico, and the European Union....more
At the end of July 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 Administration’s two-part...more
At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more
On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan, to allow certain entities to import...more
Since its enactment in 2003, Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) has been a dead letter in the law. The provision authorizes the importation of certain prescription drugs from Canada, but only if...more
Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more
As plant-based beverages appear on more store shelves, the definition of “milk” has become the center of a dispute involving legislatures, regulators, litigators and industry groups. Shook Partners Katie Gates Calderon and...more
In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more
As many readers of this blog know, the start of 2011 saw the enactment of a massive bill aimed at overhauling the nation’s food safety system to become more preventive instead of reactive to safety problems and illness...more
Beginning January 1, 2013, manufacturers, producers, and importers of medical devices must report and pay a 2.3% excise tax on the sales price of taxable medical device pursuant to Section 4191 of the Internal Revenue Code...more