What does GRASE (Generally Regarded As Safe and Effective?) mean?

In order to conclude a GRASE determination, a drug must satisfy three criteria:

• First, the particular drug must have been subjected to adequate and well-controlled clinical investigations that establish the product as safe and effective.
• Second, those investigations must have been published in the scientific literature available to qualified experts.
• Third, experts must generally agree, based on those published studies, that the product is safe and effective for its intended uses. At a minimum, the general acceptance of a product as GRASE must be supported by the same quality and quantity of scientific and/or clinical data necessary to support the approval of a new drug application.

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Dr. Eddie Valenzuela

Dr. Eddie Valenzuela is an award winning pediatrician and the founder and CEO of Pediatric Solutions, LLC.

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