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FDA Access Data Shankar, A., et al

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For BPC-157 to be compounded under 503A, it must be formally added to the FDA's positive bulk drugs list, which requires a favorable recommendation from the Pharmacy Compounding Advisory Committee (PCAC) followed by formal rulemaking

Soon after, the National Institutes of Health Revitalization Act of 1993 followed, which directed the National Institutes of Health (NIH) to establish guidelines for inclusion of women and minorities in clinical research (P.L

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