The Director’s Corner is an audio podcast series featuring the director of FDA’s Center for Drug Evaluation and Research and produced by CDER’s Office of Communications.
State of CDER 2019. Dr. Woodcock discusses what the agency is doing to address the issue of drug shortages, and how the agency is working with industry to help lessen their impact.
Drug Shortages. Dr. Woodcock discusses what the agency is doing to address the issue of drug shortages, and how the agency is working with industry to help lessen their impact.
Breakthrough Therapy Designation. Dr. Woodcock discusses this special pathway that is designed to speed drug development and the regulatory review process for promising new therapies.
State of CDER 2018. Dr. Janet Woodcock looks back on the accomplishments and highlights of 2017, and looks ahead to what is planned for 2018.
FDA's Adverse Event Reporting System (FAERS). The new FAERS public dashboard tool makes FAERS data easier to query and retrieve. Dr. Woodcock discusses the advantages of the tool as well as its limitations.
Antibiotic Misuse and Resistance. Dr. Woodcock discusses the issues surrounding the use and misuse of antibiotic medicines, as well as the emergence of antibiotic-resistant bacteria and how the issues are related.
Moving forward in 2017. Dr. Woodcock provides her perspective on the goals and priorities for CDER in 2017.
Looking back on 2016 accomplishments. 2016 was a highly productive year in CDER. Dr. Woodcock reflects on last year's major events.
Addressing the Opioid Epidemic. Dr. Woodcock discusses the FDA’s actions to implement the Opioid Action Plan, including important safety labeling changes.
Celebrating 30 years at FDA. Dr. Woodcock reflects on breakthroughs in drug research and regulation and makes some predictions for the future of drug products.
Talking translational science. Dr. Woodcock defines translational science and how it can positively affect drug development and review.
Looking back and moving forward in 2016. As we bid farewell to 2015, Dr. Woodcock discusses major events of the past year and priorities for 2016.
Dr. Woodcock discusses drug compounding from both a safety and regulatory standpoint.
Working with patient advocacy groups.
Dr. Woodcock discusses regulatory guidances drafted and submitted to FDA by patient advocacy groups.