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doi: 10.1016/j.neulet.2009.01.082 55

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They are not subject to USP sterility standards or to the pharmacist supervision rules that govern 503A operations

Additionally, a single 68 weeks double-blind placebo withdrawal randomized trial had also been conducted

The votes exposed a deep divide between the outside advisers, appointed under the Kennedy-led HHS, and the FDA's own reviewers

As a researcher who has dedicated their career to this and worked hard to get them FDA approved, its really hard to watch when the people who need these treatments the most are not able to get them.