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Re: None

Monday, 11/14/2022 12:34:52 PM

Monday, November 14, 2022 12:34:52 PM

Post# of 692404
time for another regulatory lesson, from the FDA ITSELF

Even though FDA offers extensive technical assistance, drug developers are not required to take FDA’s suggestions. As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design.

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