FDA Providing New Grants for Natural History Studies in Rare Diseases
For more information please visit The Office of Orphan Products Development.
Through our webinars and presentations, the Office of Health and Constituent Affairs brings information to you on many topics related to patient engagement, medical product (Drugs, Biologics, Devices) approval and medical product safety updates.
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Natural History Studies for Rare Diseases -Grants Program
February 29, 2016
The purpose of the video is to inform patients, patient advocates, caregivers, scientists and others who have an interest in rare diseases about the importance of natural history studies. The Food and Drug Administration’s (FDA) Office of Orphan Products Development is introducing a new grants program to support natural history studies This video is a moderated discussion between FDA physicians, a patient, a caregiver and the chair of the scientific advisory board for a patient advocacy group.
FDA Basics Webinar – Generic Drugs and FDA’s Orange Book
November 12, 2015
CDR Kendra Stewart R.Ph., Pharm.D. (USPHS), (Acting) Supervisor, Orange Book Staff talks about generic drugs and how FDA works to assure they are as safe and effective as their brand-name counterparts. CDR Stewart will also describe the Orange Book and how health care professionals and other stakeholders can use this tool and its new mobile app to access information about generic drugs.
FDA Regulatory Framework Overview
September 30, 2015
Jarilyn Dupont, J.D., Director of Regulatory Policy, Office of Policy, Office of the Commissioner provides an overview of FDA’s development of, and process for, regulatory policy decisions. Specific examples particularly relevant to patient representatives will be provided. A discussion of the regulatory tools used and stakeholder/participant involvement will be covered.
Get to Know ClinicalTrials.gov!
September 29, 2015
Rebecca Williams, Assistant Director of ClinicalTrials.gov and Dr. Jonca Bull, Assistant Commissioner of the FDA Office of Minority Health will discuss what you can expect to find on ClinicalTrials.gov and show you how to find clinical trials that may interest you
FDA Basics Webinar - The National Antimicrobial Resistance Monitoring System (NARMS): Protecting the American Public from Foodborne Illness
September 23, 2015
Heather Tate, Epidemiologist, Center for Veterinary Medicine (CVM) provides an overview of the National Antimicrobial Resistance Monitoring System (NARMS). NARMS was established in 1996 and is a partnership between FDA, CDC, and USDA to track antibiotic resistance and foodborne Salmonella, Campylobacter, and other bacteria that are among the leading bacterial causes of foodborne illness. This national public health surveillance system tracks changes in the antimicrobial susceptibility of certain enteric (intestinal) bacteria found in ill people (CDC), retail meats (FDA), and food animals (USDA) in the United States. The FDA arm of NARMS provides data about resistance in bacteria isolated from retail meats. This is important, because these data represent the major route of human exposure. NARMS produces annual summary reports on antimicrobial resistance among bacteria isolated from humans, retail meats, and food animals
FDA Basics Webinar: Drug Trials Snapshots
April 27, 2015
Dr. John Whyte, Director of CDER’s Professional Affairs and Stakeholder Engagement (PASE) staff described how the Drug Trials Snapshots provide consumers and other stakeholders with information about who participated in the clinical trials that supported FDA approval of new drugs. Dr. Whyte also discussed how the snapshots help consumers to understand any differences in the benefits or side effects among sex, race and age groups.
Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER
December 11, 2014
Dr. Tara Argual provides an overview of how the FDA Adverse Event Reports are used in the post-marketing drug safety surveillance process.
FDA Basics Webinar: CVM’s Pet Food Reporting and Recall Process
November 5, 2014
Dr. David Rotstein and Ms. Ruth Yowell discuss the many sources of information about potential concerns about pet foods including pet owners and veterinarians through FDA’s Safety Reporting Portal and Consumer Complaints. The recall process involves collaboration from many different FDA offices, from the districts to the scientific experts to determine the best course of action.
FDA Basics Webinar: Over-The-Counter Medicines and Driving
June 30, 2014
Dr. Ali Mohamadi, a medical officer on CDER’s Professional Affairs and Stakeholder Engagement staff, discussed OTC medicines that can cause drowsiness or impair driving. Also, he explained how to read the label on over-the-counter medicines to see if it is safe to drive.
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.
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.
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.
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.
2012 Patient Meeting:
FDA Working with Patients to Explore Benefit/Risk: Opportunities and Challenges
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.
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.
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.
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.
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
April 24, 2009
Office of Regulatory Affairs Overview
March 31, 2009
Drug Advertising and Marketing
February 26, 2009
Orphan Product Development
January 23, 2009
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.