Katherine Wang

1 month ago | law.com | Carrie Cohen |James Koukios |Katherine Wang

On Feb. 10, 2025, President Trump issued an Executive Order directing a 180-day suspension of enforcement of the U.S. Foreign Corrupt Practices Act (FCPA). The Executive Order mandates a temporary pause on new FCPA investigations and prosecutions while the U.S. Attorney General reviews current FCPA enforcement policies and pending investigations and enforcement actions.

2 months ago | lexology.com | Katherine Wang

The 27th International Medical Device Regulators Forum (IMDRF) conference, held this week in Japan, gathered regulators and industry representatives to discuss the organization’s five-year strategic plan. Stakeholders recommended that the IMDRF should focus on initiatives that foster regulatory efficiency, harmonization and convergence. Key areas include standardized submission format, post-approval change management, post-market surveillance and electronic IFU.

2 months ago | lexology.com | Geoffrey Lin |Katherine Wang |David McIntosh |Georgina Jones Suzuki |Manish Namireddy

Amid increasing economic tensions with the United States, China recently announced that it would ban Illumina, a U.S.-based company and the world’s leading producer of gene-sequencing machines, from importing its gene sequencers into the country.1 The Chinese government’s decision to do so is one of several retaliatory measures China has taken against American companies in response to the United States’ decision to impose additional tariffs on the country.

Jan 31, 2025 | mdpi.com | Katherine Wang |Jitesh Joshi |Youngjun Cho

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Oct 28, 2024 | mondaq.com | Katherine Wang

On October 21, 2024, the China National Medical Products Administration (NMPA) released a pilot plan that allows non-end-to-end manufacturing of biologics. The NMPA has a longstanding position to require an end-to-end production of biologics in a single manufacturing location. In other words, the drug substance and the drug product shall in principle be produced at the same manufacturing facility.