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Therapeutic Innovation & Regulatory Science|August 7, 2018
Impact of Expanded Access on FDA Regulatory Action and Product LabelingJonathan P Jarow, Richard MoscickiTherapeutic Innovation & Regulatory Science|September 19, 2018
Validation of Prognostic Marker Tests: Statistical Lessons Learned From Regulatory ExperienceRong Tang, Gene PennelloTherapeutic Innovation & Regulatory Science|September 19, 2018
Profit Evaluations When Adaptation by Design Is AppliedDaniele De MartiniTherapeutic Innovation & Regulatory Science|September 19, 2018
Pharmaceutical Pricing Policies and Procedures in Saudi Arabia: A Narrative ReviewTahir Mehmood Khan, Promise Emeka, Amal Khalil Suleiman, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity StudiesLauren Murphree Mihalcik, Megan Bausman, Paul Brown, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Statistical Analysis of Cumulative Serious Adverse Event Data From Development Safety Update ReportsBrian Davis, Harry SouthworthTherapeutic Innovation & Regulatory Science|September 19, 2018
Institutional Review Boards as Arbiters of Expanded Access to Unapproved Drugs: Time for a Change?Barbara K Redman, Alison Shea Bateman-HouseTherapeutic Innovation & Regulatory Science|September 19, 2018
Process Innovation Improves Trial Operation EfficiencyYun Jung Choi, Kyu-Pyo Kim, Sumi Park, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Use of Medical Mobile Applications Among Hospital Pharmacists in MalaysiaLong Chiau Ming, Mohammed Abdul Hameed, Denlee David Lee, et al.Therapeutic Innovation & Regulatory Science|September 19, 2018
Quality of Regulatory Decision-Making Practices: Issues Facing Companies and AgenciesMagdalena Bujar, Neil McAuslane, Sam Salek, et al.Pageof 165