Question

The initial model for drafting the ICH E6 guideline was the U.S. Food and Drug Administration (FDA) regulations for the protection of human subjects (21 CFR 50 and 56). True or False

Answer 1

The statement is true; the ICH E6 guideline was based on FDA regulations 21 CFR 50 and 56, which focus on human subject protection in clinical trials.

Step-by-step explanation:

The statement that the initial model for drafting the ICH E6 guideline was the U.S. Food and Drug Administration (FDA) regulations for the protection of human subjects (21 CFR 50 and 56) is True. The International Conference on Harmonization (ICH) E6 Guideline for Good Clinical Practice was indeed influenced by existing FDA regulations, which are designed to ensure the safety and efficacy of pharmaceuticals and protect participants in clinical trials. When it comes to drug development, both the FDA's regulations and the ICH guidelines play a critical role in the drug approval process, requiring extensive safety tests and efficacy assessments conducted by health professionals such as physicians and chemists before a drug can be marketed.