Hearing Aids: The Basic Information You Need to Know

May 21, 2012 16 comments

Did you know that May is ‘Better Hearing and Speech Month’? Do you have questions about hearing loss and hearing aids?

Learn more Wednesday, May 23, 2012 at 2:00 p.m. ET, when FDA’s Center for Devices and Radiological Health (CDRH) will host a 30-minute Webinar to discuss basic information on Hearing Aids.

The featured speaker Shu-Chen Peng, Ph.D., CCC-A, Audiologist in CDRH’s Office of Device Evaluation, will discuss what consumers need to know about hearing loss, hearing aids and the different types and styles available and how to get the most out of your hearing aids.

After the presentation, there will be an opportunity to ask questions.

For information on how to join the webinar, please visit the FDA Basics website.  There are a limited number of spots available for the Webinar, however Webinar materials will be made available on the FDA Web site.

FDA Basics Webinar: FDA Office of Minority Health – Steps to Address Health Disparities

May 17, 2012 16 comments

Scientific advances and innovative medical technologies have provided Americans with the potential for longer, healthier lives.  However, persistent and well-documented health differences exist between populations.  FDA is dedicated to addressing these disparities and achieving the highest standard of health for all.

Please join us for a webinar by FDA’s Office of Minority Health titled, “Steps to Addressing Health Disparities,” on Monday, May 21st at 2 PM EST.  The featured speaker, Michelle Yeboah, Dr. P.H., is the Acting Director of the FDA Office Minority Health.  Dr. Yeboah will give an overview of the newly established office and answer questions following the presentation.

For more information on how to join the webinar, please visit the FDA Basics website.   There are a limited number of spots available for the webinar, however all materials will be available on the FDA website.

FDA Basics Webinar: “Mini-Sentinel,” FDA’s New Tool for Monitoring the Safety of FDA-Approved Medical Products

April 18, 2012 25 comments

You probably know that health care professionals, manufacturers, and consumers often report adverse events from medical products to FDA, and that these reports are of great value to the Agency in learning about new risks of marketed products.

But did you know that FDA now has another way of monitoring medical product safety?  This new way uses information from health care records and other data sources that still protects patient privacy.  It can also provide information to FDA safety scientists in a fraction of the time it could take to get similar information from other FDA sources.

This new FDA tool is called “Mini-Sentinel,” a working pilot project of the Agency that uses secure access to the electronic health records of more than 125 million people, now enabling FDA researchers to actively seek out safety information, in addition to receiving it in reports.

FDA will host a webinar titled, “Mini-Sentinel,” FDA’s New Tool for Monitoring the Safety of FDA-Approved Medical Products highlighting this new FDA capability on April 24, 2012 at 12:00 PM ET.

There are a limited number of spots available for the webinar.  Materials from the webinar will also be made available on the FDA Basics website following the presentation.

Learn more about the webinar, including instructions about how to join.

Rapid Tracing of Food Products Prevents Illness

March 15, 2012 54 comments

Keeping our food safe is one of the missions of the FDA and the key goal of the FDA Food Safety Modernization Act signed into law by President Obama in January 2011.  The new law includes a number of provisions that will help FDA – and the producers, growers, processors and distributors – keep the food you eat safe.

One important provision is designed to help us improve how we track food along the food chain.  Those of us who work on food issues have been exploring ways to improve what we call product tracing so we can prevent a large scale outbreak when there’s a report of a contaminated food.  For example, last year people reported they got sick after eating cantaloupes contaminated with Listeria monocytogenes, and FDA worked with industry to get the cantaloupe off the shelves.

When a foodborne outbreak occurs, it is up to us, the FDA, and others, such as our industry partners, other government regulators to make sure that contaminated food products are no longer available.  By quickly tracing the food product, we can help to minimize the risk to consumers.

FDA is working closely with the food industry, other government partners, and consumer groups, to develop a national food tracing system.  Since there is no standard system in place, we began a couple of pilot programs working with the Institute of Food Technologists (IFT), a nonprofit, scientific society of professionals engaged in food science, food technology, and related professions, that has collected information and input from a variety of experts, including industry and consumer advocates.  Through these pilot projects, we are looking at practices, processes and types of technology that we might be able to use to help us better trace foods.  Nearly 1,000 individuals and organizations have been asked for their input and experiences to help us develop the pilot projects.  Ultimately, this will help us implement a strong product tracing system.

With that input and our own data, we selected the types of foods that we will be following as part of these pilot projects.  They are:

  • Tomatoes, grown in fields and greenhouses; whole and sliced; and distributed to restaurants and other institutions like hospitals, schools and nursing homes, and through grocery stores.  We are looking at tomatoes because they have been involved in a number of significant and repeat outbreaks.  Tomatoes represent a complex food supply chain and were identified by most industry associations as a top candidate for the produce related pilot;
  • Frozen Kung Pao-style dishes that contain peanut products, red pepper spice, and chicken were chosen because they contain multiple ingredients involved in significant outbreaks.  They also offer a variety of supply chain distribution channels, and, like tomatoes, can involve both domestic and imported products.
  • Jarred peanut butter and dry, packaged peanut/spice were added to the pilot projects to enhance the complexity of the pilots.

The results of the pilot projects will be completed this summer, and we expect to be able to use the information to help us develop a comprehensive product tracing system.  By being better prepared to successfully identify the source of outbreaks through more rapid traceback and traceforward investigations, FDA, working closely with the food industry, will be better positioned to prevent future outbreaks and illness.

For more information visit:

Updates on the pilot projects are also available at the IFT web site.

Sherri McGarry

Senior Advisor, Coordinated Outbreak Response and Evaluation Network

Office of Foods, FDA

Bring FDA Tobacco Content to Your Website for Free

March 8, 2012 23 comments

As the Digital Communication and New Media Director at FDA’s Center for Tobacco Products, I am thrilled to announce the launch of a new content syndication pilot project that provides free tobacco-related web content for use on other websites. This new service helps meet the growing demand for up-to-date, reliable public health web content by empowering FDA stakeholders to add value and depth to their sites by integrating the latest FDA tobacco content. Syndication also furthers FDA’s open government goals by enhancing public collaboration and participation with FDA content.

As a pilot project, we are unveiling this new service with more than 40 web pages of tobacco content available. Over the coming months we will work with stakeholders to make improvements, test functional capabilities and learn from their experiences. We will use these lessons, as well as data from surveys and metrics, to improve the service and inform possible expansion across other FDA health topics.

We’ve already learned a lot from the innovative work the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) have done to advance this technology. Through their efforts they have improved the consistency of health information, reduced content sharing barriers and provided vital information more cheaply and easily. In the last several years, CDC led the use of this technology to foster collaboration and health information sharing, while providing metrics to highlight the success of their syndication efforts. HHS has worked tirelessly to facilitate information sharing within and across agencies, which gave us many insights into how this service is being used in the field.

I am excited to showcase our FDA content syndication services and hope that you will want to learn more about how the technology works, the benefits and how you can get started. For those of you wanting to try content syndication, simply sign up, choose the content you would like to syndicate and copy and paste our web code into your website. Our syndicated content is automatically updated ensuring you always have the latest, most accurate information. It really is that easy—and if you get tripped up, there are tools available to help guide you through the process.

I encourage you to check out our new content syndication hub and let us know what you think. Your feedback and comments will help us improve the site and learn about technical issues that need to be addressed. Please also let us know what FDA tobacco content you would like to syndicate by requesting new pages to be added to the syndication hub. Thank you so much for your time. I am eager to learn from this pilot project and watch our syndication efforts evolve.

Ann Aikin

Digital Communication and New Media Director,

FDA Center for Tobacco Products

Report on Exploratory Program to Increase Access to the Agency’s Compliance and Enforcement Data

February 17, 2012 12 comments

Recently, the FDA released a report titled, “Food and Drug Administration Transparency Initiative: Exploratory Program to Increase Access to the Agency’s Compliance and Enforcement Data.” that identified eight new initiatives adopted by FDA Commissioner Margaret A. Hamburg, M.D. to explore ways to increase the transparency of FDA’s compliance and enforcement data.  These initiatives are based on draft proposals FDA released on October 3, 2011, as well as on comments the public submitted in response to those proposals.

Focused on making the compliance and enforcement data FDA receives and generates more accessible and user-friendly, these initiatives are part of FDA’s ongoing efforts to enhance the public’s understanding of the Agency’s decisions and promote accountability of the Agency and industries it regulates. 

Commissioner Hamburg launched FDA’s Transparency Initiative in June 2009.  The report issued recently, which advances that initiative, is part of FDA’s response to President Obama’s Presidential Memorandum on Regulatory Compliance, which directed federal agencies to make compliance information more publicly available, easily accessible, downloadable and searchable online.  A task force of key FDA leaders overseeing the Transparency Initiative endorsed all the specific initiatives presented in this latest report. 

We invite the public to review the Agency’s progress in implementing other action items and draft proposals related to the Transparency Initiative at: 

http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative.

Daniel Sigelman

Senior Policy Advisor and Transparency Initiative Coordinator

Canadian and U.S. Agencies Partner to Modernize Food Safety

December 12, 2011 37 comments

As Deputy Commissioner for Foods at the Food and Drug Administration, I led a delegation to Ottawa on October 21 to meet with officials from the Canadian Food Inspection Agency (CFIA) and Health Canada to discuss how to best cooperate on our efforts to modernize our respective food safety systems.  I also had the opportunity to hear from Canadian industry representatives on their ideas of how FDA could implement the Food Safety Modernization Act (FSMA) in the most efficient manner as we continue to protect public health.  This trip furthered our efforts to reach out and collaborate with our colleagues abroad who will be our partners as we put FSMA in place, especially those provisions concerning imported food.

The trip also allowed both sides to step back and reflect on the importance of the U.S.-Canadian relationship in achieving the goals that FSMA has laid out for us, in line with FDA’s mission to protect public health.  On the trade front, Canada is the United States’ largest trading partner in terms of agricultural imports.  Because so much food is exchanged across our border every day, our governments share a keen interest in ensuring that this food is safe for our consumers.  However, we also have an obligation to make sure that companies are not unnecessarily burdened.

A major highlight of the trip for me was the industry outreach session where I received comments and questions on FSMA directly from Canadian industry.  We listened as industry described several different types of preventive control programs that they believe could be useful for FDA as we implement FSMA requirements.  Industry also expressed keen interest in the Foreign Supplier Verification Program, especially with regard to its proposed scope and applicability.  We also answered questions on topics ranging from the definition of “importer” to exceptions for small business to user fees.

Our delegation also engaged on a technical level with our Canadian counterparts to investigate areas where we could cooperate on food safety modernization efforts.  Exchanging inspection and compliance information, with a view toward leveraging each other’s resources, was an activity that both sides agreed to pursue.  Also, Canada expressed interest in working with FDA’s FSMA imports implementation team on best practices for import controls, laboratory accreditation and third party certification, among other modernization areas.

The FDA looks forward to continue working with our CFIA and Health Canada counterparts in the months ahead to strategize, prioritize, and exchange ideas on how we can cooperate to accomplish our common public health goals. Our respective food safety systems are already well-developed, but we recognize the need to make continual improvements.  Our modernization efforts will not necessarily be identical, but I know that close cooperation between U.S. and Canadian regulators, such as we had during our trip, will allow us to move forward together to protect public health and continue as strong trade partners.

Michael R. Taylor
Deputy Commissioner for Foods

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