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To get their gene or cell therapies through health technology appraisals, companies need to agree to gather longer-term evidence, be upfront about what treatments can really deliver and remember to ask for patient input.
Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.
Legislative proposals described in the US FDA’s FY 2020 budget request justification document would give the agency more authority to oversee business continuity planning at pharmaceutical companies with the idea of preventing shortages of essential drugs.
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