From Our Perspective
Latest From Our Perspective
FDA Opens Doors for More Treatments for Rare Diseases through the New START Pilot Program
Dr. Patrizia Cavazzoni and Dr. Peter Marks discuss how the FDA's new START Pilot Program aims to accelerate the development of treatments for rare diseases. By offering enhanced support and guidance to selected sponsors, this initiative helps generate high-quality data and brings novel drugs and biologics to patients more efficiently.
Education Efforts to Help Increase Biosimilar Understanding and Acceptance
Sarah Ikenberry, M.A., explains the FDA's comprehensive efforts to enhance the understanding and acceptance of biosimilars among healthcare providers and the public. These educational initiatives clarify the benefits, safety, and efficacy of biosimilars, promoting their broader adoption in the U.S. healthcare system.
CDER’s OGD and EMA’s Parallel Scientific Advice Pilot Program for Complex Generics Works to Increase Harmonization and Bring Generic Drugs to Patients
Sarah Ibrahim, PhD, highlights the collaborative effort between CDER’s OGD and EMA to streamline the development of complex generics. This initiative aims to harmonize regulatory approaches and provide simultaneous feedback from both agencies, facilitating the development of generic drugs that reach patients faster.
Previous From Our Perspective
2023
- FDA’s 50 Years of Experience with Cannabis Research Helping to Support Tomorrow’s Cannabis Drug Development
- Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
- CDER Takes Measures to Tackle Stimulant Use Disorder
- CDER Collaborates with Global Regulators on Pharmaceutical Quality Assessments and Inspections
- CDER’s Efforts to Expand Opioid Disposal Options
- FDA Actions to Continue to Ensure the Safety of the Nation’s Drug Supply
- CDER Continues to Advance Rare Disease Drug Development with New Efforts, Including the Accelerating Rare Disease Cures (ARC) Program
- CDER’s Continued Efforts to Widen Naloxone Access
- Risk Evaluation and Mitigation Strategies (REMS), Part 2 - Implementation: Challenges and Opportunities
- A Two-Part Series: Risk Evaluation and Mitigation Strategies (REMS) Program
2022
- FDA’s Role in Helping a Critical Medical Isotope Meet Sufficient Supply in the US for First Time
- FDA Issues Draft Guidances on Real-World Evidence, Prepares to Publish More in Future
2021
- 50 Years of Progress in Treating Patients with Cancer
- FDA Holds Workshop to Discuss the Safe Use of Benzodiazepines
- 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