Guidance documents are typically developed by a range of stakeholders including:
1. Regulatory Bodies: Organizations like the FDA and EPA in the United States, and the European Medicines Agency (EMA) in Europe, play a significant role. 2. International Organizations: Groups such as the ISO (International Organization for Standardization) and the OECD (Organisation for Economic Co-operation and Development) contribute to global standards. 3. Academic Institutions: Universities and research labs often contribute to the scientific basis for these documents. 4. Industry Groups: Consortia and industry alliances also develop guidelines to ensure that their products meet regulatory and safety standards.
