Therapeutic Innovation & Regulatory Science

Improving Expanded Access in the United States: The Role of the Institutional Review Board

Development of Prescription Drug Information Leaflets: Impact of Cognitive Effort and Patient Involvement on Prescription Medication Information Processing

A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC)

How Does Regulatory Practice Create Discrepancies in Drug Label Information Between Asian and Western Countries? Different Label Information for Direct Oral Anticoagulants Approved in the United States, Europe, Korea, and Japan

Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption

Use of Proxy Variables to Determine the Impact of Protocol Complexity on Clinical Research Site Productivity

Youth Experience With Community Pharmacy Services and Their Perceptions Toward Implementation of Medication Therapy Management Services by Community Pharmacists in the Western Region of Saudi Arabia

Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned

What to Know About Medicines With New Active Ingredients Approved in FY 2016/2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016

Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials:: Results of a Preliminary Study