News & Events > The Collection

News & Events > The Collection

2015

• From our perspective: The importance of the physical characteristics of generic drugs
• From our perspective: Atrial fibrillation, oral anticoagulant drugs, and their reversal agents
• From our perspective: The U.S. drug supply chain and patient safety
• From our perspective: Evaluating the changing landscape of health care antiseptics
• From our perspective: Patients deserve quality medications

2014

• From our perspective: Statisticians at CDER Part 1, roles and responsibilities
• From our perspective: Statisticians at CDER Part 2, activities outside of applications
• From our perspective: Clinical biomarker qualification
• From our perspective: Assessing, safeguarding pharmaceutical quality
• Generic Drug User Fee Amendments (GDUFA) of 2012 regulatory science program
• Atrial fibrillation and new oral anticoagulant drugs
• FDA actions reduce drug shortages but critical issues remain
• Drug development tools and the EXACT PRO initiative, part 1
• Drug development tools and the EXACT PRO initiative, part 2
• Drug development guidelines for Hepatitis C virus
• Drug safety -- past, present and the future

2013

• Enrichment Design Studies should Enhance Signals of Effectiveness

2012

• Personalized medicine: A biological approach to patient treatment