Department of Health and Human Services

Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

Listen to Webinars With FDA Experts

Webinars Library

2014

Drug Shortages and the FDA Response
May 1, 2014

This webinar provides an overview of U.S Drug Shortages and the FDA response.

Developing Personalized Medicines
April 22, 2014

Dr. Mike Pacanowski from the Office of Clinical Pharmacology provides an overview of the development of Personalized Medicine.

2013

FDA's Role in ClinicalTrials.gov
September 17, 2013

This webinar provides an overview of the Office of Good Clinical Practice and the FDA's responsibilities with ClinicalTrials.gov.

FDA Review of Clinical Outcome Assessments: Ensuring the Patient Perspective in Drug Development Trials
August 20, 2013

This webinar provides on overview on some of the challenges FDA has found in using Patient Reported Endpoints and discuss current initiatives on utilizing the patient perspective in medical product approvals.

Design and Performance of Clinical Trials: An overview
June 29, 2013

Dr. Anne Zajicek from the National Institutes of Health provides an overview on how clinical trials are designed and evaluated.

Drug Development 101: Industry Perspective
June 18, 2013

Beginning with an overview of how drugs are developed, Robert Kowalski, Novartis Pharmaceuticals Corporation, discusses innovation in drug development, from new therapies for diseases to clinical research design to new treatment modalities.

FDA’s Experience with Risk Mitigation Strategies
February 20, 2013

Danielle Smith, Center for Drug Evaluation and Research, FDA, reviews the strategies and tools in place within the Agency to minimize the risk of medical products to patients throughout the product’s lifecycle.

Medical Devices in the Home: What FDA is Doing
January 11, 2013

With more medical devices being used in the home, Mary Weick-Brady, Center for Device and Radiological Health, FDA, explains the Agency’s Home Use Medical Device Initiative designed to increase device safety through consumer education, development of manufacturer guidelines, and other activities.

2012

Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change
November 15, 2012

Listen to an overview of the history of FDA drug regulation with special consideration to treatments for chronic fatigue syndrome/myalgic encephalomyelitis.

FDASIA Provision Overview and Patient Input
September 18, 2012

Dominic J. Cirincione, Office of Health and Constituent Affairs, FDA, sheds light on the Food and Drug Administration Safety and Innovation Act, known as FDASIA, and in particular Section 1137, which emphasizes patient involvement in medical product discussions and development.  

Biosimilar Biological Products
July 16, 2012

Rachel Sherman, Center for Drug Evaluation and Research, unravels the complexities of biosimilar biologics and discusses the Agency’s efforts to establish licensure for these products. 

Drug Development in Pediatric Oncology
June 26, 2012

Amir Shahlaee, Office of Hematology and Oncology Products, FDA, offers a broad overview of the prevalence, biology, and treatment of pediatric cancers and discusses the role regulators can play in advancing this field. 

Personalized Treatment in Lung Cancer
March 29, 2012

Shakun Malik, Center for Drug Evaluation Research, FDA, discusses the deadliest cancer around the globe, lung cancer. She offers an overview of the prevalence and types of lung cancer and explains targeted therapies and personalized treatment currently available for people with lung cancer.

Post-marketing Safety Signals
February 23, 2012

Ann Corken Mackey, Center for Drug Evaluation Research, sheds light on how FDA discovers and evaluates signals that indicate a potential safety risk for a medical product, regulatory actions they can take to ensure public safety, and how they communicate this new information to the public. 

Medication Errors
January 30, 2012

Medication errors happen for a number of reasons—abbreviations, look-alike names, and similar packaging and drug labels. Matthew Grissinger, Institute for Safe Medication Practices, and Cathy Miller, Center for Drug Evaluation Research, FDA, discuss these factors and explore strategies for preventing medication errors. 

2011

Bad Ad Program
November 29, 2011

Sheetal Patel, Center for Drug Evaluation Research, FDA, explores the importance of truth in advertising, how FDA is working to keep drug promotion truthful, and explains how to report misleading ads. 

Federal Advisory Committee Act (FACA)
September 12, 2011

FDA Advisory Committees provide independent expert advice to the agency on a range of complex scientific, technical, and policy issues. Dominic Cirincione, Office of Health and Constituent Affairs, FDA, explains the legislation from which the more than 900 committees are governed—the Federal Advisory Committee Act. 

2010

Home Use Initiative
September 30, 2010

Mary Weick-Brady ad Diana Rivi, Center for Devices and Radiological Health, explain the Agency’s Home Use Medical Device Initiative and discuss why and how to report problems with medical devices to FDA to ensure public safety. 

Patient Labeling
August 31, 2010

La Shawn Griffiths and Sharon R. Mills, Center for Drug Evaluation and Research, FDA, break down the components of a drug label—medication guide, patient package insert, and instructions for use—and explain how the agency is working to enhance readability for consumers. 

Sentinel Initiative
July 29, 2010

The national electronic safety monitoring system, a result of the Sentinel Initiative, strengthens FDA’s ability to monitor medical products once they are available to the public. Melissa Robb, Sentinel Initiative, FDA, describes the initiative and explores its role in augmenting existing safety monitoring systems.  

Postmarketing Safety of Drugs & Therapeutic Biologics
June 7, 2010

Jo Wyeth and Gwen Zornberg, Center for Drug Evaluation and Research, FDA, explain how FDA identifies and evaluates safety issues associated with drugs and biologics to manage risk. 

Safe Use Initiative
April 9, 2010

More than 4 million visits to the emergency department, doctor, or other outpatient settings are related to medication injuries.  Karen Weiss and Dale Slavin, FDA, discuss the sources of medication errors and how they can be prevented.  

Expanded Access Programs
March 19, 2010

Richard Klein, Office of Health and Constituent Affairs, FDA, explains the history of the Expanded Access Programs and how patients who have exhausted all treatment options may be able to get access to an investigational drug through the programs.  

2009

FDA MedWatch and Patient Safety
December 16, 2009

Learn about FDA’s adverse event reporting system, MedWatch, and find out how the Agency monitors the safety of drugs and devices once they are on the market.

FDA Transparency Initiative
October 7, 2009

Learn about FDA’s agency-wide activities to make its information more useful, understandable, and readily available to the public while simultaneously protecting confidential information.

Critical Path Update
August 19, 2009

See the collective work underway to modernize scientific and technical tools and harness information technology to evaluate and predict the safety, effectiveness, and manufacturability of medical products.

Regulation of Medical Devices
May 29, 2009
Counterfeit Drugs
April 24, 2009
Office of Regulatory Affairs Overview
March 31, 2009
Drug Advertising and Marketing
February 26, 2009
Orphan Product Development
January 23, 2009

2008

Generic Drugs and Bioequivalence
December 12, 2008

Find out how generic drugs, those that have the same quality, same safety, and same strength as brand name drugs, are developed and approved; and learn the basics of biosimilar biologics and the Agency’s efforts to establish licensure for these products.

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