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SOURCE: FDA, news release, Dec

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PEM is characterised by a delayed onset, prolonged duration, and an intensity disproportionate to the precipitating exertion (15, 16)

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They are granted a narrow legal exemption from the standard New Drug Application (NDA) process only if they strictly adhere to the requirements of the following statutory pathways: Section 503A (Traditional Compounding): Regulates state-licensed pharmacies compounding for identified individual patients based on a valid, patient-specific prescription