What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?” at https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194909.htm and

First read:
1. “What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?” at
https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194909.htm
and
2. Contrary to Misconceptions, a Final Guidance is Not a Final Rule at

then give your thought on the following:
What purpose does Good Guidance Practices serve, and why do you think there was a need for FDA to adopt Good Guidance Practices? Can you present historic evidence to support your theory?
What role do you think guidances have in FDA’s regulatory function? Give some real-life examples where FDA issued a regulation, and subsequently issued guidances interpreting or clarifying the regulation, and explain why you think the guidance was necessary and whether the guidance fulfilled its intended purpose.

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