Title: ParagonRx | Pharmaceutical Risk Management and Appropriate Use Programs
Description: ParagonRx | Minimizing Risk and Optimizing Use of Medical Products
Keywords:ParagonRx, failure mode and effect analysis, FMEA, REMS, Risk Evaluation and Mitigation Strategy, REMS guidance, Proposed REMS, REMS design, REMS development, REMS program, REMS approval, REMS elements, REMS assessment, REMS effectiveness, approved REMS, deemed REMS, REMS supporting document, REMS document, pharmaceutical risk management, risk assessment, risk management, risk mitigation, risk evaluation, benefit-risk, benefit risk,
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FDA, regulatory, guidance, FDA draft guidance, FDA approval, FDA submission, approval, submission, NDA, FDAAA, PDUFA, MedGuide, medication guide, communication plan, EASU, Elements to Assure Safe Use, contingency plan, RiskMAP, evidence-based, RxFMEA, appropriate use, patient safety, safety, drug safety, pharmaceutical safety, pharmaceutical marketing, medication, medications, biologics, generic drug, generics, medication use, medical devices, Jeff Fetterman, Gary Slatko(View Less)
