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Lois Sheng Liu

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Lois is a member of the Firm's Litigation & Government Enforcement Practice Group in the FDA sub-group, based in Washington, DC. Prior to joining Baker McKenzie, Lois worked as an associate for another multinational law firm. As a former pharmacist and a research fellow at a major teaching hospital, Lois has an extensive understanding of various regulatory issues related to clinical research and development, marketing strategy, product approval, and government enforcement activities.
In Product Regulation & Liability

International: FDA to enhance unannounced inspections of foreign manufacturing facilities in countries including China

by , and 4 Mins Read

On 6 May 2025, the US Food and Drug Administration (FDA) announced that it will expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for US consumers and patients. The announcement came one day after the White House issued an Executive Order instructing FDA to provide regulatory relief to promote domestic production of critical medicines and improve FDA’s risk-based inspection regime to enhance routine inspections of foreign facilities.

In International

International: FDA to enhance unannounced inspections of foreign manufacturing facilities in countries including China

by , and 4 Mins Read

On 6 May 2025, the US Food and Drug Administration (FDA) announced that it will expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for US consumers and patients. The announcement came one day after the White House issued an Executive Order instructing FDA to provide regulatory relief to promote domestic production of critical medicines and improve FDA’s risk-based inspection regime to enhance routine inspections of foreign facilities. The expansion will build upon FDA’s existing Foreign Unannounced Inspection Pilot Program in India and China, with the aim of ensuring that foreign facilities will receive the same level of regulatory oversight and scrutiny as domestic facilities.

In Product Regulation & Liability

North America: Supreme Court Unanimously Rejects Challenge to FDA’s Approval of Mifepristone

by , and 5 Mins Read

On June 13, 2024, the Supreme Court of the United States (SCOTUS) unanimously held in FDA v. Alliance for Hippocratic Medicine that plaintiff physicians and pro-life medical associations lacked Article III standing to challenge the U.S. Food and Drug Administration’s (FDA) regulation of mifepristone, a prescription drug primarily used in terminating pregnancy. Following the ruling, mifepristone remains available and approved. Also importantly, SCOTUS reasoned that a desire to make a drug less available for others does not establish standing to sue FDA. Since SCOTUS focused on standing as a threshold issue, the broader question of whether the FDA acted within its authority and jurisdiction to approve mifepristone remains unanswered.