Core Viewpoint - The FDA has announced an immediate review of clinical trials involving the transfer of live human cells from American citizens to laboratories in China and other "hostile countries" for genetic engineering, indicating a shift towards stricter biotechnology restrictions against China [4][5]. Group 1 - The FDA's review is prompted by concerns that international transfers and genetic engineering operations may occur without patient knowledge or consent, potentially leading to the misuse of sensitive genetic data by foreign governments, including those of hostile nations [5]. - The Biden administration's data security rules set in December 2024 included export controls but allowed a "comprehensive exemption" for clinical trial biological samples, creating regulatory loopholes that permitted participation from Chinese-funded enterprises [5]. - FDA Commissioner Marty Makary emphasized the importance of the integrity of the biomedical research system and stated that actions are being taken to protect patients, rebuild public trust, and defend America's biomedical leadership [5].