The Collection | From Our Perspective
2021
- FDA Approval Demonstrates the Role of Real-World Evidence in Regulatory Decision-Making on Drug Effectiveness
- CURE ID Moves to Automated Data Collection in Light of COVID Pandemic
- FDA’s Decision to Approve New Treatment for Alzheimer’s Disease
- Generic Drugs in the 21st Century: FDA’s Actions Create Transparency and Value for Complex Generic Product Development
- FDA and Duke-Margolis Host Workshop on Scientific and Ethical Considerations for Including Pregnant People in Clinical Trials
2020
- The Orange Book at 40: A valued FDA resource continually enhanced by user input
- Bad Ad Program at 10, Educating Healthcare Providers to Recognize and Report Potentially False or Misleading Prescription Drug Promotion
2017
2016
- Biosimilar product labeling with Dr. Leah Christl
- Encouraging drug development for rare diseases with Dr. Jonathan Goldsmith
- Working to prevent proprietary drug name confusion with Dr. Lubna Merchant
- Expedited oncology drug approvals with Dr. Richard Pazdur
2015
- Helping to Ensure the safety and effectiveness of sunscreens with Dr. Theresa Michele
- The importance of the physical characteristics of generic drugs with Dr. John R. Peters
- Atrial fibrillation, oral anticoagulant drugs, and their reversal agents with Dr. Ellis Unger
- The U.S. drug supply chain and patient safety with Dr. Ilisa Bernstein
- Patients deserve quality medications with Dr. Lawrence Yu
2014
- Statisticians at CDER Part 1, roles and responsibilities with Dr. Lisa LaVange
- Statisticians at CDER Part 2, activities outside of applications with Dr. Lisa LaVange
- Clinical biomarker qualification with Dr. Shashi Amur
- Atrial fibrillation and new oral anticoagulant drugs