Opioid Blister Packs Need Study Before Mandate, Groups Urge
AAM, Upsher-Smith, APhA, and Cigna tell US FDA that packaging requirement will increase manufacturing and drug costs, create reimbursement hurdles and reduce access to medicines. Daiichi-Sankyo supports agency's proposal.
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CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.