Selected Regulatory Notes

• FDA News Release: FDA Announces Major Steps to Implement Real-Time Clinical Trials (April 28, 2026).
• Federal Register: AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information.” (04/29/2026)
• FDA Draft Guidance: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. (Jan. 2025)

Scientific / Legal Reading Index

• Ryu K, Park G, Cho WK. Emerging insights into transcriptional condensates. Exp Mol Med. 2024 Apr;56(4):820-826. doi: 10.1038/s12276-024-01228-9. Epub 2024 Apr 25. PMID: 38658705; PMCID: PMC11059374.
• Argyris Papantonis, A. Marieke Oudelaar. 2025. Mechanisms of Enhancer-Mediated Gene Activation in the Context of the 3D Genome. Annual Review Genomics and Human Genetics. 26:163-188
• Uceda, A.B., Mariño, L., Casasnovas, R. et al. An overview on glycation: molecular mechanisms, impact on proteins, pathogenesis, and inhibition. Biophys Rev 16, 189–218 (2024).
• Google Loper Bright Enterprises v. Raimondo, 600 U.S. ___ (2024) - Supreme Court case overturning the 1984 Chevron Doctrine regarding Administrative statutory interpretation.
• Google LLC v. Oracle America, Inc., 593 U.S. 1 (2021) – Case involving to what extent certain parts of software code can be utilized as fair use.
• Diamond v. Chakrabarty, 447 U.S. 303 (1980) – Landmark Supreme Court decision regarding patentability of genetically modified bacteria.