Executive Order 14281: The End of Fair Lending Law Enforcement Through Use of the Disparate Impact Legal Theory?
How Employers Can Adapt to Immigration Policy Shifts
Hot Topics in International Trade - What it means to believe
Executive Order Breakdown: President Trump's Vision for College Sports and NIL Reform — Highway to NIL Podcast
Conversation with Former SEC Chief Economist Dr. Jessica Wachter on Investment Management Rulemaking at the Commission – PE Pathways
2 Gurus Talk Compliance: Episode 57 — The Tom on His Highhorse Edition
10 For 10: Top Compliance Stories For the Week Ending August 9, 2025
Hill Country Authors – Exploring the Challenges of a Green Transition with Tom Ortiz
Taxing Intelligence: AI's Role in Modern Tax Administration
LathamTECH in Focus: Move Fast, Stay Compliant
Daily Compliance News: August 6, 2025, The Spanking Banks Edition
10 For 10: Top Compliance Stories For the Week Ending, August 2, 2025
Everything Compliance: Episode 158, The No to Corruption in Ukraine Edition
Daily Compliance News: July 30, 2025, The Corruption Kill Business Edition
The Presumption of Innocence Podcast: Episode 66 - Tariff Uncertainty and Compliance Risks for Businesses
Legal Implications of the Supreme Court's Ruling on Universal Injunctions
Daily Compliance News: July 9, 2025, The TACO Don Caves Again Edition
The Presumption of Innocence Podcast: Episode 65 -The Power of Interpretation: Constitutional Meaning in the Modern World
Driving Digital Security: The FTC's Safeguards Rule Explained — Moving the Metal: The Auto Finance Podcast
The Labor Law Insider: NLRB Does a U-Turn on Make-Whole Settlement Remedies, Part II
In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs. On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO...more
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more
In Tuesday's Report: FDA lists essential medicines and medical countermeasures, Trump plans health official replacement, FDA expands remote monitoring exemption list, WHO director self-quarantines, and other U.S. White House...more
Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration (FDA) announced that it published a list of 223 drug and...more
As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more
On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more
NEW SENATOR JOINS HEALTH COMMITTEE - Newly sworn-in Sen. Kelly Loeffler, R-Ga., is the newest member of the Senate Health, Education, Labor and Pensions Committee....more
On December 10, 2019, the House Democrats and Trump administration reached an agreement on the United States-Mexico-Canada Agreement (USMCA), which would replace the North American Free Trade Agreement (NAFTA) of 1994....more
On Monday, December 2, 2019, The Wall Street Journal reported that the Trump administration is considering reducing the 12-year data exclusivity period for biologic drugs set forth in the Biologics Price Competition and...more
Recently, the U.S. Food and Drug Administration, or the FDA, announced enhancement of the FDA's Paragraph IV Patent Certification List (the List) as part of the agency's stated goal of bringing more generic drugs to market...more
On October 1, the Trump administration announced that it had secured a new trade agreement with Canada and Mexico. The United States-Mexico-Canada Agreement (USMCA) would replace the North American Free Trade Agreement...more
Late on September 30, an agreement (USMCA) was reached between the United States, Mexico and Canada which modernizes the 24 year old North American Free Trade Agreement (NAFTA)....more
A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more
President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more
As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more
In public debates over the Affordable Care Act (ACA), also known as Obamacare, biosimilars are rarely, if ever, mentioned. But the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA), was in...more
As previously posted, President Trump has stated that he planned to issue a notification of intent to withdraw from the Trans-Pacific Partnership (TPP), which is a proposed trade agreement between several pacific countries...more
President-elect Trump’s plans for his first 100 days in office include “cutting the red tape at the FDA” and “speed[ing] the approval of life-saving medications.” Here, we consider specific steps Trump could take–without or...more
This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception. Two of Trump’s stated policies...more