Eliminating MedGuide-Only REMS Merits PDUFA-Style Deadlines, PhRMA Says
FDA should take no more than three months deciding whether a Medication Guide can be pulled out of an existing Risk Evaluation and Mitigation Strategy, the Pharmaceutical Research and Manufacturers of America believes.
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FDA Drops Restricted Access Requirement For Amgen’s Nplate And GSK’s Promacta
FDA’s decision to modify the risk program for thrombocytopenia treatments may influence CMS to drop Nplate from its list of potential National Coverage Determinations.
Oncology Has Different Risk Management Standards, FDA’s Pazdur Acknowledges
Risk mitigation in the oncology setting is unique, largely because of the different benefit/risk ratio, but also because the therapeutic area has "a de facto restricted distribution system," as FDA Office of Oncology Drug Products Director Richard Pazdur put it.