FDA: Food and Drug Administration Safety and Innovation Act (FDASIA) and Patient Focused Drug Development Read more
FDA Releases Final Risk Evaluation and Mitigation Strategies (REMS) for Extended Release/Long Acting Opioids Including a Prescriber Education Program Read more
FDA: Risk Evaluation and Mitigation Strategies (REMS) Paper on Program Evaluations and Outcomes Read more
FDA: PFUFA – Senate Introduces Bi-Partisan Legislation on Drug Shortages and Fast Track Product Approvals, and Other Issues Read more