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Thursday, April 08, 2021 9:08:33 AM
Unfortunately, it depends on the FDA's interpretation. Not what the public or medical professionals like myself think.
Guidances “do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.”
If I remember right the FDA contradicts it's own regulations when prividing guidance on stem cells being a drug.
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