Join FDA leaders as they provide their insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics.
The program will be on hiatus starting Jan. 20, 2021.
|Ep. #||Title and Link to Transcript||Link to Podcast||Runtime|
FDA Commissioner Dr. Stephen Hahn, and FDA Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah discuss FDA's COVID-19 efforts, including the drug development process for a COVID-19 treatment.
|Listen (MP3, 13MB)||13:40|
Dr. Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs, welcomes Toby Lowe, the Associate Director of the Office of In Vitro Diagnostics and Radiological Health, to discuss the basics of diagnostic tests for COVID-19.
|Listen (MP3, 9MB)||09:38|
FDA Commissioner Stephen M. Hahn, M.D., returns to FDA Insight to discuss food safety issues during the COVID-19 pandemic.
|Listen (MP3, 10MB)||11:17|
Clinical Trials and Treatments for COVID-19
Dr. Patrizia Cavazzoni, the acting director of FDA’s Center for Drug Evaluation and Research, joins Dr. Shah for an in-depth discussion on clinical trials and treatments for COVID-19. A list of clinical trials are available at https://clinicaltrials.gov.
|Listen (MP3, 15MB)||15:58|
In Part 1 of FDA Insight’s vaccine series, Dr. Shah welcomes Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, to discuss the basics of COVID-19 vaccine development.
|Listen (MP3, 11MB)||11:41|
Dr. Peter Marks returns for a more comprehensive discussion on vaccines as they relate to COVID-19. Find out more about “herd immunity,” Operation Warp Speed, and vaccine distribution in this episode.
|Listen (MP3, 14MB)||15:45|
A “Topical” Discussion on Sunscreen
During the summer, fun in the sun is a high priority for many families, but what do you really know about that sunscreen protecting you? Dr. Terri Michele, the Director of the Office of Non-Prescription Drugs in FDA’s Center for Drug Evaluation and Research, joins Dr. Shah to discuss sunscreen safety.
|Listen (MP3, 10MB)||11:00|
Dr. Shah welcomes Bakul Patel, the director of Digital Health at FDA’s Center for Devices and Radiological Health, to discuss telemedicine, digital health tools, and FDA’s new Digital Health Center of Excellence.
|Listen (MP3, 11MB)||12:22|
Dr. Judy McMeekin, the Associate Commissioner for Regulatory Affairs, joins Dr. Shah on the show to discuss FDA's fight against health fraud during the COVID-19 pandemic.
|Listen (MP3, 6MB)||06:08|
Valerie Jensen, the Associate Director of the Drug Shortages staff in FDA's Center for Drug Evaluation and Research, joins Dr. Shah for a discussion on drug shortages and how the COVID-19 pandemic can impact the drug supply chain.
|Listen (MP3, 9MB)||09:17|
The Opioid Epidemic and COVID-19 Pandemic
Dr. Shah welcomes Megan Moncur, FDA’s Associate Director of Opioid Policy, to the show to discuss the opioid epidemic and how it’s been impacted by the COVID-19 pandemic.
|Listen (MP3, 20MB)||21:23|
E-Cigarettes and the National Youth Tobacco Survey
Mitch Zeller, Director of FDA's Center for Tobacco Products, joins Dr. Shah in a discussion on e-cigarettes (or vapes) and the 2020 National Youth Tobacco Survey results. For more on how you can stop using tobacco products, go to https://everytrycounts.gov.
|Listen (MP3, 18MB)||20:00|
Dr. Shah welcomes Dr. Susan Mayne, Director of FDA's Center for Food Safety and Applied Nutrition, to discuss nutrition and chronic disease prevention, including health disparities.
|Listen (MP3, 17MB)||18:50|
Dr. Shah welcomes Dr. Steve Solomon, Director of FDA's Center for Veterinary Medicine, to discuss the work CVM is doing in combating antimicrobial resistance.
|Listen (MP3, 12MB)||13:15|
An Insight into Women’s Health
Dr. Kaveeta Vasisht, FDA's Associate Commissioner for Women's Health, joins FDA Insight to discuss the Office of Women's Health's work to advance the health of women through scientific programs, policy development, research, education and outreach.
|Listen (MP3, 14MB)||14:55|
Advisory Committee on COVID-19 Vaccines
Dr. Peter Marks, FDA's Director of the Center for Biologics Evaluation and Research, returns for his third episode to provide an update on COVID-19 vaccines and to discuss the upcoming Vaccines and Related Biological Products Advisory Committee meeting.
|Listen (MP3, 9MB)||09:39|
On this week's episode, Dr. Shah brings Dr. Peter Marks back to the show to discuss the importance of getting the flu vaccine. For more information about the flu vaccine, visit: https://www.fda.gov/flu
|Listen (MP3, 13MB)||14:00|
Dr. Shah welcomes Elizabeth Jungman, director of CDER’s Office of Regulatory Policy, to talk about hand sanitizers and the COVID-19 pandemic.
|Listen (MP3, 11MB)||11:54|
Personal Protective Equipment and COVID-19
Dr. Shah welcomes Dr. Suzanne Schwartz, director of FDA’s Office of Strategic Partnerships and Technology Innovation at the Center for Devices and Radiological Health, for a discussion on personal protective equipment and its critical role in helping to reduce the spread of COVID-19.
|Listen (MP3, 16MB)||17:24|
Rare Diseases and Orphan Products
Dr. Shah welcomes Dr. Janet Maynard, director of FDA’s Office of Orphan Products Development, for a discussion on the agency’s work advancing evaluation and development of products that demonstrate promise for the diagnosis and treatment of rare diseases.
|Listen (MP3, 14MB)||15:00|
Minority Health and Health Equity
Dr. Anand Shah and Rear Adm. Richardae Araojo, Associate Commissioner of Minority Health, discuss the FDA’s efforts to address minority health disparities among diverse racial and ethnic populations.
|Listen (MP3, 12MB)||13:25|
Dr. Jeffrey C. Baker, Deputy Director of the FDA’s Office of Biotechnology Products in the Center for Drug Evaluation and Research, joins Dr. Shah for a discussion on how FDA’s efforts help innovation and implementation of Advanced Manufacturing technologies regarding food and drug safety.
|Listen (MP3, 10MB)||11:18|
Gail Bormel from the Office of Compliance in FDA’s Center for Drug Evaluation and Research joins Dr. Shah for a discussion on drug compounding and its contribution to fighting COVID-19.
|Listen (MP3, 10MB)||10:57|
New Era of Smarter Food Safety
Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, joins Dr. Shah for a discussion on the New Era of Smarter Food Safety and how its blueprint impacts FDA’s COVID-19 response.
|Listen (MP3, 18MB)||19:31|
Pandemic Recovery and Preparedness Plan (PREPP)
Join FDA Commissioner Stephen M. Hahn, M.D. and Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D. for their final episode of FDA Insight as they discuss FDA’s Pandemic Recovery and Preparedness Plan, or PREPP. After this episode, the program is scheduled to go on hiatus.
|Listen (MP3, 11MB)||11:54|