The Company noted that the ProStrakan Abstral REMS program is further supported by McKesson Specialty Care Solutions, which manages some of the industry's most rigorous REMS programs mandated by the FDA to-date. Its integrated Chopard Mille Miglia CH-13 support solutions include strategic consultation, design and implementation, FDA submission assistance, registries, clinical data collection and risk monitoring, program reporting, and managed distribution. With the aid of RelayHealth's pharmacy network reach, McKesson enables pharmaceutical manufacturers to create REMS programs that enhance their relationships with retail pharmacies, expand patient access to drug therapies, and attain a higher level of patient safety and outcomes.
ProStrakan Group plc, an international pharmaceutical company based in the UK, announced that it has chosen RelayHealth Pharmacy Solutions as its connectivity partner and McKesson Specialty Chopard Mille Miglia CH-78 Solutions to administer its U.S. Food and Drug Administration (FDA)-approved Abstral Risk Evaluation and Mitigation Strategy (REMS) program.Abstral is a disintegrating sublingual tablet formulation of fentanyl Chopard Mille Miglia Chronograph CH-10 indicated for the management of pain in cancer patients 18 years and older who are already receiving, and are already tolerant to, opioid analgesics for their underlying persistent cancer pain.Through RelayHealth's approach to leveraging its network, coupled with the REMS experience of McKesson Specialty Care Solutions, the Company said the
Abstral REMS program is a technology-advanced REMS solution of its kind. The Abstral REMS program enables retail pharmacy participation in REMS programs without disrupting workflows."RelayHealth's innovative connectivity technologies in pharmacies and McKesson Specialty Care Solutions' deep REMS experience is an excellent fit for our Abstral REMS program," said Abid Karim, President of Global Commercial Operations, Chopard Mille Miglia GMT CH-73.According to a release, the FDA requires pharmaceutical manufacturers to ensure that the benefits of a marketed drug or biological product outweigh the risks to consumers. For some classes of drugs, the FDA has stipulated the institution of a REMS program to help minimize a patient's chance of experiencing adverse effects while undergoing therapy.
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