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FDA, parent agency HHS divided over emergency contraceptive prescription status
SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.
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FDA modifies REMS for two drugs to treat low platelet counts
SILVER SPRING, Md. — Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.