is being presented by David Rothkopf, President, of MEDIcept and airs on Tuesday, March 13th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Many companies make subtle changes to their devices over time. However, those subtle changes can add up to the point where the current design no longer matches the product deemed safe and effective by the FDA. Whether you just received clearance for your product or it was last cleared in the last century, the FDA has stepped up enforcement on modifications to devices without notification. During site investigations, the FDA is looking at design changes and reviewing all the changes between now and when you last received a 510(k) clearance.
In July 2011 the FDA released a draft guidance document on 510(k) device modification and when to submit a new 510(k) for an existing device. This document reflects the current thinking of the FDA, and will replace the present guidance released in 1997. Are you ready? Do you know the configuration of your product when it was last cleared? Those “letter to file” changes might no longer be acceptable. This audio conference presentation reviews the new guidance document, looks at how to perform a design gap analysis on a device, and discusses what to do when you realize you probably should submit a new 510(k).
Thursday, March 1, 2012
Monday, February 27, 2012
FDA Update – Responding to Unsolicited Requests for Off-Label Information
is being presented by Marian J. Lee & Dr. Beverly H. Lorell, Partner & Senior Medical and Policy Advisor, with King & Spalding LLP and airs on Thursday, March 8th, 2012. For more details, or to register please visit our site at www.fxconferences.com
FDA recently released a significant draft guidance on how manufacturers and distributors of drugs and medical devices may respond to unsolicited requests for information about off-label uses of their products. This audio conference presentation analyzes the far-reaching implications of that new guidance for company practices and procedures regarding these scientific communications, and also what it means for the use of off-label promotion as the basis for enforcement action by FDA and other federal authorities. Our speakers examine the impact of the agency's newly defined distinctions between solicited and unsolicited requests for information, and non-public and public information requests, including those requests arising in emerging electronic media. The presentation focuses on providing practical tips and pitfalls to avoid in implementing this new draft guidance.
FDA recently released a significant draft guidance on how manufacturers and distributors of drugs and medical devices may respond to unsolicited requests for information about off-label uses of their products. This audio conference presentation analyzes the far-reaching implications of that new guidance for company practices and procedures regarding these scientific communications, and also what it means for the use of off-label promotion as the basis for enforcement action by FDA and other federal authorities. Our speakers examine the impact of the agency's newly defined distinctions between solicited and unsolicited requests for information, and non-public and public information requests, including those requests arising in emerging electronic media. The presentation focuses on providing practical tips and pitfalls to avoid in implementing this new draft guidance.
Tuesday, February 21, 2012
Writing Web Content That Works
is being presented by Janice Redish, President, of Redish & Associates, Inc and airs on Wednesday, March 7th, 2012. For more details or to register, please visit our site at www.fxconferences.com
People come to websites for the content. They come to fulfill a need, to do a task, to get the answer to a question. Clear navigation, good design, and search engines that work are all critical, of course, but they are all there to support the content. Are you paying enough attention to the content on your website – both to what your messages are and to how you are presenting those messages? In this audio conference presentation, reknowned speaker and author Ginny Redish teaches attendees to think about web content and web writing in new ways. Starting from the premise that every visit to your website is a conversation started by the site visitor, the presentation demonstrates for attendees why people skim and scan, provides a better understanding of when people do read online and when they don't, and reviews a few basic best practices on how to write for the busy people who come to your website.
People come to websites for the content. They come to fulfill a need, to do a task, to get the answer to a question. Clear navigation, good design, and search engines that work are all critical, of course, but they are all there to support the content. Are you paying enough attention to the content on your website – both to what your messages are and to how you are presenting those messages? In this audio conference presentation, reknowned speaker and author Ginny Redish teaches attendees to think about web content and web writing in new ways. Starting from the premise that every visit to your website is a conversation started by the site visitor, the presentation demonstrates for attendees why people skim and scan, provides a better understanding of when people do read online and when they don't, and reviews a few basic best practices on how to write for the busy people who come to your website.
Monday, February 20, 2012
Conducting Medical Device Studies in the UK
is being presented by Janette Benaddi, CEO, of Medvance and airs on Tuesday, March 6th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The MHRA has been making a concentrated effort to streamline its approval process, and thereby to encourage medical device research in the UK. Among the recent changes, Research Ethics Committees (REC) now have special medical device committees, and the guidance governing submission of device applications to REC is being updated. A new Health Research Authority hs been established. The MHRA and RECs have integrated their application systems, and it will soon move to a new, unified portal. The list of changes is lengthy, and it should add up to a regulatory environment more conducive to device research. However, there are still key points to consider, and things you can do to make the regulatory journey as painless as possible.
This audio conference presentation provides attendees with the information they need to conduct successful studies in the UK, reviewing recent changes in the regulatory landscape and examining what they mean for device companies. Our speaker draws upon extensive experience, and shares tips for navigating through the approval processes quickly and efficiently, ensuring a timely start to studies in the UK.
The MHRA has been making a concentrated effort to streamline its approval process, and thereby to encourage medical device research in the UK. Among the recent changes, Research Ethics Committees (REC) now have special medical device committees, and the guidance governing submission of device applications to REC is being updated. A new Health Research Authority hs been established. The MHRA and RECs have integrated their application systems, and it will soon move to a new, unified portal. The list of changes is lengthy, and it should add up to a regulatory environment more conducive to device research. However, there are still key points to consider, and things you can do to make the regulatory journey as painless as possible.
This audio conference presentation provides attendees with the information they need to conduct successful studies in the UK, reviewing recent changes in the regulatory landscape and examining what they mean for device companies. Our speaker draws upon extensive experience, and shares tips for navigating through the approval processes quickly and efficiently, ensuring a timely start to studies in the UK.
Tuesday, February 14, 2012
Early Development Considerations for Inhalation Drug Products
is being presented by Dr. Nahed Mohsen, Biomedical Engineering Consultant and airs on Thursday, March 1st, 2012. For more details, or to register please visit our site at www.fxconferences.com
Inhalation drug products are delivered via the lungs by aerosol delivery devices, and are used to deliver therapies to treat local and systemic diseases. The advantages of these products are ease of use and the small doses required to achieve the desired treatment. However, the required dose and efficacy of delivery is highly dependent on various developmental design factors which may not be readily apparent. These include drug formulation, aerosol delivery system, interaction between the formulation and the delivery system, packaging of formulation and delivery system as well as human maneuvering with the delivery system – known as hand-lung coordination. Although an inhalation drug product may be comprised of an approved drug and an approved device, new scientific and technical issues may emerge when the drug and device are combined, packaged or used together.
In this audio conference presentation, our speaker draws upon a case study involving a dry powder drug product to address the scientific and technical challenges raised by inhalation drug product packaging, including selection of the component of the primary packaging and how it affects product performance, safety, effectiveness, and quality of the combination product.
Inhalation drug products are delivered via the lungs by aerosol delivery devices, and are used to deliver therapies to treat local and systemic diseases. The advantages of these products are ease of use and the small doses required to achieve the desired treatment. However, the required dose and efficacy of delivery is highly dependent on various developmental design factors which may not be readily apparent. These include drug formulation, aerosol delivery system, interaction between the formulation and the delivery system, packaging of formulation and delivery system as well as human maneuvering with the delivery system – known as hand-lung coordination. Although an inhalation drug product may be comprised of an approved drug and an approved device, new scientific and technical issues may emerge when the drug and device are combined, packaged or used together.
In this audio conference presentation, our speaker draws upon a case study involving a dry powder drug product to address the scientific and technical challenges raised by inhalation drug product packaging, including selection of the component of the primary packaging and how it affects product performance, safety, effectiveness, and quality of the combination product.
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