1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH E2A: clinical safety data management: definitions and standards for expedited reporting; 1994. https://database.ich.org/sites/default/files/E2A_Guideline.pdf.
2. U.S. Food and Drug Administration. Investigational new drug safety reporting requirements for human drugs and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans: final rule; 2010. https://www.govinfo.gov/content/pkg/FR-2010-09-29/pdf/2010-24296.pdf.
3. U.S. Food and Drug Administration. Guidance for industry and investigators: safety reporting requirements for INDs and BA/BE studies; 2012. https://www.fda.gov/media/79394/download.
4. Jarow JP, Casak S, Chuk M, et al. The majority of expedited investigational new drug safety reports are uninformative. Clin Cancer Res. 2016;22(9):2111–3.
5. US Food and Drug Administration. Draft guidance for industry: sponsor responsibilities—safety reporting requirements and safety assessment for IND and bioavailability/ bioequivalence studies; 2021. https://www.fda.gov/media/150356/download. Accessed 10 Oct 2023.