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This study, over an 8 month period, evaluated 300 individuals between 65 and 96 years of age

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law, compounding may occur through patient-specific prescriptions (503A pharmacies) or by FDA-registered outsourcing facilities (503B), and is generally permitted only when there is a legitimate clinical need or drug shortage

The main safety issue was brain swelling and bleeding, a problem common to all plaque-targeting drugs

Paul Offit, a member of the FDA's advisory committee, said data based on mice studies is not sufficient to justify authorizing the new boosters