For Health Professionals

FDA Expert Commentary and Interview Series on Medscape

As part of the continuing collaboration between FDA and Medscape disclaimer icon, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices.

The complete terms and framework of the partnership with Medscape are described in the Memorandum of Understanding.

Interviews

 

Xray knee

Safety in Pediatric Imaging disclaimer icon

Featuring Vasum Peiris, MD, MPH; Laurel Burk, PhD; and Gail M. Rodriguez, PhD, January 2018

 

 

Dr. Gerald Dal Pan, Director, FDA Office of Surveillance and Epidemiology

Postmarket Drug Safety: The View From the FDA disclaimer icon

Featuring Gerald Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, FDA Center for Drug Evaluation and Research, May 2017

 

 

Dr John Whyte

Does Your Patient Need Both an Opioid and Benzodiazepine? disclaimer icon

Featuring Dr. John Whyte, Director of Professional Affairs and Stakeholder Engagement, FDA Center for Drug Evaluation and Research, November 2016

 

 

Focus on Orphan Disease R&D at FDA

The Focus on Orphan Disease R&D at FDA disclaimer icon

Featuring Dr. John Whyte, Director of Professional Affairs and Stakeholder Engagement, and Dr. Gayatri Rao, Director of the Office of Orphan Products Development, FDA Center for Drug Evaluation and Research, October 2016

 

 

Dr. Suzanne Schwartz

FDA Issues Warning on Heater-Cooler Use During Surgery, Citing Risk for Serious Bacterial Infection disclaimer icon

Featuring Dr. Suzanne Schwartz, Associate Director for Science and Strategic Partnerships FDA Center for Devices and Radiological Health, October 2016

 

Douglas Throckmorton

Abuse-Deterrent Opioids: What You Need to Know disclaimer icon

Featuring Douglas Throckmorton, MD, Deputy Director, Regulatory Programs FDA Center for Drug Evaluation and Research, August 2016

 

 
 

Leah Christl, PhD

The Brave New World of Biosimilars disclaimer icon

Featuring Leah Christl, PhD, Associate Director, Therapeutic Biologics, FDA Center for Drug Evaluation and Research, May 2016

 

 
 

Doctor at computer

Navigating the New Clozapine REMS disclaimer icon

Featuring Mitchell Mathis, MD, Director, Division of Psychiatry Products, FDA Office of New Drugs, December 2015

 

 
 

Commentary tPA and TNK Mix-ups: Clearing Up the Confusion

tPA and TNK Mix-ups: Clearing Up the Confusion disclaimer icon

Featuring Lt. Chi-Ming (Alice) Tu, PharmD, FDA Division of Medication Error Prevention and Analysis, September 2015

 

 
 

Richard Klein is interviewed about expanded access

Expanded Access: Recourse for Patients Out of Options disclaimer icon

Featuring Richard Klein, Director, FDA Patient Liaison Program, July 2015

 

Health professional washing hands

Are Healthcare Antiseptics Toxic to Staff and Patients? disclaimer icon

Featuring Theresa Michele, MD, Director, FDA Division of Nonprescription Drug Products, June 2015

 

 

group of children

Montelukast's Underrecognized Adverse Drug Events disclaimer icon

Featuring Sally Seymour, MD, and Erika Torjusen, MD, MHS, FDA Center for Drug Evaluation and Research, Division of Pulmonary, Allergy, and Rheumatology, March 2015

 

 

 pregnant woman

FDA Updates Labels for Pregnant and Breastfeeding Women disclaimer icon

Featuring Melissa S. Tassinari, PhD, and Jeanine Best, MSN, RN, PNP, FDA Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health, January 2015

 

 

 Gayatri R. Rao, MD, JD, Director, Office of Orphan Products Development, FDA

Targeting Drugs for Rare Diseases disclaimer icon

Featuring Gayatri R. Rao, MD, JD, Director, FDA Office of Orphan Products Development, November 2014

 

 

 Margaret A. Hamburg, MD

Balancing the Risks, Benefits for 310 Million Patients disclaimer icon

Featuring Margaret A. Hamburg, MD, Commissioner, U.S. Food and Drug Administration, November 2014

 

 Ebola Virus

Responding to Ebola: The View From the FDA disclaimer icon

Featuring Luciana Borio, MD, FDA Acting Deputy Chief Scientist and Assistant Commissioner for Counterterrorism Policy in the Office of Counterterrorism and Emerging Threats, August 2014

 

 

 FDA Approval 2.0

FDA Approval 2.0: Dr. Kandzari Interviews Dr. Bill Maisel disclaimer icon

A discussion with Dr. Bill Maisel, Deputy Center Director for Science, FDA Center for Devices and Radiological Health, on strategies to expedite FDA approval while maintaining scientific rigor. April 2014

 

 

 New Food Labels: Information Clinicians Can Use

The New Food Labels: Information Clinicians Can Use disclaimer icon

Featuring Jessica Leighton, PhD, MPH, Senior Advisor for Nutrition Science and Policy, and Claudine Kavanaugh, PhD, MPH, RD, Health Scientist, FDA Office of Foods and Veterinary Medicine, April 2014

 

 

 Dr. Anne Pariser

FDA's Rare Disease Program: A Rare Opportunity to Help Kids disclaimer icon

Featuring Anne Pariser, MD, Associate Director for Rare Diseases, Office of New Drugs, and Andrew Mulberg, MD, Deputy Director, Division of Gastroenterology and Inborn Error Products, FDA Center for Drug Evaluation and Research, March 2014

 

 

 Capt. Valerie Jensen, RPh

Critical Intravenous Solution Shortages disclaimer icon

Featuring Capt. Valerie Jensen, RPh, Associate Director, Drug Shortages Program, FDA Center for Drug Evaluation and Research, February 2014

 

 Mitch Zeller, JD, Director, FDA Center for Tobacco Products   

Preventing Teen Tobacco Use disclaimer icon

Featuring Mitch Zeller, JD, Director, FDA Center for Tobacco Products, February 2014

 

 

photo of Tablets

Acetaminophen, Opioids, and Safety disclaimer icon

Featuring Sharon Hertz, MD, Deputy Director, Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research, February 2014

 

 

Redefining 'Latex-Free' disclaimer icon

Featuring Geetha C. Jayan, MVSc, PhD, PMP, and Michael T. Bailey, PhD, FDA Center for Devices and Radiological Health, January 2014

 

 

Trans Fat Food Label

Removing Trans Fats From Foods: The FDA's View disclaimer icon

Featuring Dennis Keefe, PhD, Director, FDA Office of Food Additive Safety, November 2013

 

 

Breast Implants: The View From the FDA disclaimer icon

Featuring Binita Ashar, MD, MBA, FACS, and David Krause, PhD, FDA Office of Device Evaluation, July 2013

 

 

Flu and the FDA disclaimer icon

Featuring Margaret A. Hamburg, MD, Commissioner, U.S. Food and Drug Administration, January 2013

 

 

Telling the FDA: Why Contact Lens Adverse Events Matter disclaimer icon

Featuring Bernard P. Lepri, OD, MS, MEd, and Michelle Tarver, MD, PhD, FDA Office of Device Evaluation, November 2012

 

 

Decorative Contact Lenses: Truly Frightening disclaimer icon

Featuring Michelle Tarver, MD, PhD, FDA Office of Device Evaluation, October 2012

 

 

Contact Lenses: The Risks You Need to Know disclaimer icon

Featuring Bernard P. Lepri, OD, MS, MEd, FDA Office of Device Evaluation, October 2012

 

 

Quinine and Leg Cramps: Not Worth the Risk  disclaimer icon

Featuring Hala H. Shamsuddin, MD, Medical Officer, Office Of Antimicrobial Products, FDA Center for Drug Evaluation and Research, October 2012

 

 
 

The New Opioid REMS: The FDA View disclaimer icon

Featuring Gerald J. Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, FDA Center for Drug Evaluation and Research, September 2012

 

 

 Elliot Cowan, PhD, Chief, Product Review Branch,  Division of Emerging and Transfusion Transmitted Diseases 

At-Home Rapid HIV Testing: An Interview With FDA disclaimer icon

Featuring Elliot Cowan, PhD, Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, FDA Center for Biologics Evaluation and Research, July 2012

 

 

FDA Expert Interview 

Statins: The Story Behind the Label Changes disclaimer icon 

Featuring Amy Egan, MD, MPH, Deputy Director for Safety, Division of Metabolism and Endocrinology Products, March 2012

 

 

FDA Expert Interview

Simvastatin 80 mg: An FDA Expert Interview disclaimer icon

Featuring Amy Egan, MD, MPH, Deputy Director for Safety, Division of Metabolism and Endocrinology Products, August 2011

 

 

Ticagrelor: The View From the FDA

Ticagrelor: The View From the FDA disclaimer icon

Featuring Norman Stockbridge, MD, PhD, Director, Division of Cardiovascular and Renal Products, July 2011

 

 
The Changes in Sunscreen Labeling

The Changes in Sunscreen Labeling disclaimer icon

Featuring Reynold Tan, PhD, Interdisciplinary Scientist, Division of Nonprescription Regulation Development, July 2011

 

 
 
 

Back to the top 

Video Programs 

 

FDA Drug Safety Communications:
What You Need to Know When You Need to Know It 
disclaimer icon

Featuring Dr. Gregory Busse, Team Lead for Drug Safety Communication in the FDA Center for Drug Evaluation and Research, July 2012

 

 
 
Dr. Gerald Dal Pan, Acting Director, FDA Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research  
 

A Short Tutorial on REMS: The FDA Perspective disclaimer icon 

Featuring Dr. Gerald Dal Pan, Acting Director, FDA Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, April 2012

 

 
 
Dr. Diane Mitchell, Assistant Director for Science in the FDA Center for Devices and Radiological Health
 

Repairing Pelvic Organ Prolapse: What's Best? disclaimer icon  

Featuring Dr. Diane Mitchell, Assistant Director for Science for FDAs Center for Devices and Radiological Health, April 2012

 

 
What To Do About Misleading Drug Ads FDA Expert Series on Medscape

What To Do About Misleading Drug Ads disclaimer icon 

Featuring Michael Sauers, Team Leader for FDAs Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research, December 2011

 

 
 
The Problem with Drug Shortages

The Problem With Drug Shortages disclaimer icon

Featuring Jouhayna Saliba, PharmD, Senior Regulatory Program Manager for FDA's Drug Shortage Program in the Center for Drug Evaluation and Research, November 2011

 

 
 
Current and Future State of Drug-Eluting Stents thumbnail

Current and Future State of Drug-Eluting Stents disclaimer icon

Featuring Ashley Boam, BSE, MSBE, Chief of FDA's Interventional Cardiology Devices Branch, and Andrew Farb, MD, Medical Officer and Senior Reviewer in the Interventional Cardiology Devices Branch, October 2011

 

 
 
Surgical Fires: How They Start and How to Prevent Them

Surgical Fires: How They Start and How to Prevent Them disclaimer icon

Featuring Stephanie Joseph, FDA Biomedical Engineer, Center for Devices and Radiological Health and Dr. Kenneth Silverstein, Chair, Department of Anesthesiology and Medical Director, Perioperative Services at Christiana Care Health System, October 2011

 

 

•	FDA Commissioner: "Safety Science" Key to Drug Regulation

FDA Commissioner: "Safety Science" Key to Drug Regulation disclaimer icon

Featuring Dr. Margaret Hamburg, Commissioner of the FDA, February 2011

 

 

Food Recalls: FDA Takes Preventive Approach

Food Recalls: FDA Takes Preventive Approach disclaimer icon

Featuring Michael Taylor, FDA Deputy Commissioner for Foods, February 2011

 

 

Safe Use of Drugs Requires Reports From Clinicians

Safe Use of Drugs Requires Reports From Clinicians disclaimer icon

Karen Weiss, MD, MPH, Program Director for the FDA's Safe Use Initiative, February 2011

 

 

Are You Prescribing Unapproved Drugs?

Are You Prescribing Unapproved Drugs? disclaimer icon

Charles E. Lee, MD, Medical Officer in the Office of Compliance, March 2011

 

 

Back to the top 

Past Continuing Education Program

The Bad Ad Program and Prescription Drug Promotion CME

The Bad Ad Program and Prescription Drug Promotion disclaimer icon

The goal of this activity is to educate healthcare professionals and students about the role they can play in helping the FDA ensure that prescription drug advertising and promotion is truthful and not misleading.

October 2013

 

 

Melissa M. Truffa, BSPharm, Associate Director, Division of Pharmacovigilance, FDA Office of Surveillance and Epidemiology

Tell It to the FDA: The Adverse Drug Event Case Reportdisclaimer icon  

Featuring Melissa M. Truffa, BSPharm, Associate Director, Division of Pharmacovigilance, FDA Office of Surveillance and Epidemiology, and Anna Fine, PharmD, Director, Health Professional Liaison Program, FDA Office of Special Health Issues. Learn how to prepare a relevant narrative to describe the adverse event in your case report for the FDA’s MedWatch system.

October 2012

 

 

Anna Fine, PharmD, Director, Health Professional Liaison Program, FDA Office of Special Health Issues

Your Patient Has an Adverse Reaction to a Drug: How to Report to FDA's MedWatch disclaimer icon

Featuring Anna Fine, PharmD, Director, Health Professional Liaison Program, FDA Office of Special Health Issues. Learn how to identify the types of adverse events and product problems or errors that should be reported to FDA.

July 2012

 

 

Panel discussion for REMS Program for Transmucosal Immediate-Release Fentanyl Products

REMS Program for the Transmucosal Immediate-Release Fentanyl Products disclaimer icon

Panel discussion featuring Theresa A. Toigo, RPh, MBA (Associate Director, Drug Safety Operations, FDA) and Sharon Hertz, MD (Deputy Director, Division of Anesthesia, Analgesia, and Addiction Products, FDA). 

This CME/CE activity will explain why a risk evaluation and mitigation strategy (REMS) is needed to ensure safe and effective use of the transmucosal immediate-release fentanyl products.

July 2012

 

 

Panel discussion moderated by Claudia Karwoski, Director, Division of Risk Management, CDER

Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses, and Pharmacists disclaimer icon 

Panel discussion moderated by Claudia Karwoski, PharmD, Director, Division of Risk Management, FDA Center for Drug Evaluation and Research. This CME/CE activity addresses the use of risk evaluation and mitigation strategies, an important and evolving topic that has wide-reaching implications for physicians, nurses, and pharmacists.  

May 2012

 

 

Panel discussion moderated by Dr. Leonard Sacks, Acting Director, FDA Office of Critical Path Programs

Transforming a Clinician Into an Investigator: What Does It Take? disclaimer icon

Panel discussion moderated by Dr. Leonard Sacks, Acting Director, Office of Critical Path Programs at FDA. This CME/CE activity will help clarify the responsibilities of clinical investigators and address some of the challenges that investigators face today. 

November 2011

 

 

Back to the top 

 

Continuing Education Programs

 

 

Page Last Updated: 06/15/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English