Warning Label Final Guidance Recommends Use Of Numeric Adverse Reaction Rates
Also, known or possible hypersensitivity reactions should be listed under contraindications in drug labeling, FDA says in final guidance.
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Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
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Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
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The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.