Updates and Insights on Quality and Inspections. The newsletter, which will come out roughly monthly, will discuss new developments in FDA inspections and enforcement, and its regulation of ...
In In re Nussbaum Lowinger LLP, the Bankruptcy Court for the Southern District of New York (the Court) dismissed Chapter 11 ...
National security considerations are rapidly reshaping the life sciences industry, with evolving U.S. and European regulations affecting research, clinical trials, supply chains, investment, data ...
On August 11, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule that would convert the currently voluntary Generally Recognized as Safe (GRAS) notification program into a ...
The U.S. Department of Justice (DOJ) has continued to enforce the Foreign Corrupt Practices Act (FCPA) in 2026, while also seeking to dismiss certain high-profile FCPA prosecutions that began before ...
On July 13, 2026, the U.S. Department of Justice (DOJ), acting on behalf of the Federal Trade Commission (FTC), filed a complaint and proposed final judgment in the United States District Court for ...
On July 13, 2026, the U.S. Department of Defenser (DOD) temporarily suspended Cybersecurity Maturity Model Certification (CMMC) Phase II requirements — originally scheduled to take effect on November ...
On June 22, 2026, China’s Ministry of Commerce (MOFCOM) and Ministry of Finance (MOF) both announced restrictive measures targeting a total of 56 U.S. entities, likely in response to the U.S.
The HHS Office of Inspector General is also evaluating whether to update the safe harbor regulations under the federal Anti-Kickback Statute or the exceptions to the civil monetary penalty provision ...
On May 29, 2026, the Office of Management and Budget (OMB), joined by nearly every federal grantmaking agency, published a proposed rule that would dramatically alter the framework for federal ...
The life sciences sector continues to be a growing area of interest for national security controls, as U.S. pharmaceutical companies have increasingly partnered with Chinese firms for development, ...
On May 1, 2026, President Trump issued Executive Order 14404 (“EO 14404” or “the Order”), expanding the scope of U.S. sanctions targeting Cuba. Building upon the national emergency the president ...
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