The FDA issued a warning letter to Otsuka America Pharmaceutical regarding misleading information on the Busulfex website for leukemia treatment. The FDA found that the website omitted safety risks, minimized other risks, and made unsubstantiated claims about efficacy. In particular, information for children was mentioned but did not fully disclose risks. The website also overstated benefits and misreported statistics not backed by evidence. The FDA warned that websites must accurately represent drug information and not use misleading marketing language.
RTC POVs: FDA Warning Letter for Copaxone, March 2012RTC
In March of 2012, the FDA released a warning letter for the drug Copaxone for its patient testimonial website. In this POV, Dii's Ruth Lim discusses the FDA's concerns and the implications for pharma companies and marketers.
FDA Regulation of Advertising -- FDA EnforcementMichael Swit
November 9, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
The FDA's October 2011 warning letter to Otsuka demonstrates the importance of making accurate and fully supported claims and associations on pharmaceutical websites.
Since our first Perspectives of 2012 was published so close to President's Day, we took Presidential technology as our theme and decided to ask the question: What if the Presidents had used technology? If tools like YouTube, Facebook and Twitter had been available to our historical leaders, how would they have used them?
The search giant Google has gone back to its roots with the launch of a new technology – “Google Knowledge Graph”. The technology, launched on May 16, leverages the idea of a “semantic Web” focused entirely on user experience. Now when users input a search query on Google, relevant and related information about that query will be provided in a box to the right of the results page. These results will go above and beyond what has previously been provided on search results pages. While users will benefit from more relevant and accessible search results, marketers may see changes in their organic rankings and side-site metrics.
RTC POVs: FDA Warning Letter for Copaxone, March 2012RTC
In March of 2012, the FDA released a warning letter for the drug Copaxone for its patient testimonial website. In this POV, Dii's Ruth Lim discusses the FDA's concerns and the implications for pharma companies and marketers.
FDA Regulation of Advertising -- FDA EnforcementMichael Swit
November 9, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
The FDA's October 2011 warning letter to Otsuka demonstrates the importance of making accurate and fully supported claims and associations on pharmaceutical websites.
Since our first Perspectives of 2012 was published so close to President's Day, we took Presidential technology as our theme and decided to ask the question: What if the Presidents had used technology? If tools like YouTube, Facebook and Twitter had been available to our historical leaders, how would they have used them?
The search giant Google has gone back to its roots with the launch of a new technology – “Google Knowledge Graph”. The technology, launched on May 16, leverages the idea of a “semantic Web” focused entirely on user experience. Now when users input a search query on Google, relevant and related information about that query will be provided in a box to the right of the results page. These results will go above and beyond what has previously been provided on search results pages. While users will benefit from more relevant and accessible search results, marketers may see changes in their organic rankings and side-site metrics.
FDA Guidance for Food and Drug Labelling
#peivandpirouzi #training #canada #pirouzi #international #funding #immigrants #refugees #canada #immigration #education
“FUNCTIONAL FOODS: CLAIMS AND LABELING” -- AN OVERVIEW OF THE LAWMichael Swit
Presentation to the Regulatory Affairs Professionals Society (RAPS) & University of Southern California School of Pharmacy conference on Dietary Supplements & Supplemental Foods." November 2000, Pasadena, CA., covering:
♦ What is a Functional Food
♦ Claims under Nutritional Labeling and Educations Act (NLEA)
♦ FDAMA Claims
♦ FTC Advertising Regulation
The Difference Between Intended Use, Indications for Use, and Instructions fo...EMMAIntl
No matter what your product is, at some point in your regulatory journey you will need to appropriately determine your product’s intended use, indications for use, and instructions for use. For most people, these three items sound like they should mean the same thing, but for the FDA, they are all different. Your company must use these terms correctly because incorrect use of them could lead to issues with the FDA granting your device approval or clearance...
In late 2011, the FDA released a document addressing how the pharmaceutical industry can and should respond to requests about off-label drug usage. This POV provides more information about the guidance document, highlights the key issues, and offers use cases to consider in the digital realm.
FDA Device Software Regulation by NetZealous LLCJimmyGFlores
The exponential growth of software and its level of complexity and use have brought both advantages as well as challenges. While the advantage is the advancement and multiplicity of use in medical devices; the challenge relates to the regulatory aspect.
"Pharmacovigilance in Crisis: Drug Safety at a Crossroads, 2018".Rosmirella Cano Rojas
Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers.
The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine- learning to automate pharmacovigilance operations.
These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs.
Issue 39: Preventing pediatric medication errors | Joint Commission
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_39.htm?print=yes[9/20/2010 11:54:27 AM]
Sentinel Event Alert
April 11, 2008
Issue 39, April 11, 2008
Preventing pediatric medication errors
Errors associated with medications are believed to be the most common type of medical error and are a significant cause of
preventable adverse events. Experts agree that medication errors have the potential to cause harm within the pediatric
population at a higher rate than in the adult population. For example, medication dosing errors are more common in pediatrics
than adults because of weight-based dosing calculations, fractional dosing (e.g., mg vs. Gm), and the need for decimal points.
“Research shows that the potential for adverse drug events within the pediatric inpatient population is about three times as high
as among hospitalized adults,” (1) says Stu Levine, PharmD, informatics and pediatric specialist, Institute for Safe Medication
Practices, an organization which serves as a resource for information on how to improve medication practices. “For this reason,
health care providers must pay special attention to the specific challenges relating to the pediatric population.”
A new study—the first to develop and evaluate a trigger tool to detect adverse drug events in an inpatient pediatric population
—identified an 11.1 percent rate of adverse drug events in pediatric patients. This is far more than described in previous
studies. The study also showed that 22 percent of those adverse drug events were preventable, 17.8 percent could have been
identified earlier, and 16.8 percent could have been mitigated more effectively. (2)
Children are more prone to medication errors and resulting harm because of the following:
Most medications used in the care of children are formulated and packaged primarily for adults. Therefore, medications often
must be prepared in different volumes or concentrations within the health care setting before being administered to children.
The need to alter the original medication dosage requires a series of pediatric-specific calculations and tasks, each
significantly increasing the possibility of error.
Most health care settings are primarily built around the needs of adults. Many settings lack trained staff oriented to pediatric
care, pediatric care protocols and safeguards, and/or up-to-date and easily accessible pediatric reference materials, especially
with regard to medications. Emergency departments may be particularly risk-prone environments for children. (3)
Children—especially young, small and sick children—are usually less able to physiologically tolerate a medication error due to
still developing renal, immune and hepatic functions.
Many children, especially very young children, cannot communicate effectively to providers regarding any adverse effects that
medications may be causing.
During calendar years 2006-2007, USP’s ...
Biosimilars: Regulatory and Clinical ConsiderationsCovance
Other considerations for clinical studies are that the regulations are written with some flexibility, and although clinical studies have been required thus far, they are not mandated by the regulations. Perception from sponsors is that innovators make process changes all the time that impact structure and no clinical study is done because of good analytical characterization so why are biosimilars different? With solid analytical and functional data, we should continue to challenge regulators on the need for clinical studies.
RTC Perspectives, May 2012: Thank You, Star TrekRTC
This quarter, "Perspectives" focused on Star Trek and looked at the developments in culture, technology, medicine and even travel that we owe to this iconic series. Contributions come from the Dii, Account, Creative, Strategy, and PM teams at RTC, and original cover art is by Joshua Scott.
RTC POVs: Facebook Timeline for Pharma Brand Pages, April 2012RTC
Facebook has rolled out its Timeline feature for brand pages, and is offering more options than ever for brands to connect with their fans within the social network. However, there are implications for pharma that marketers must be aware of.
FDA Guidance for Food and Drug Labelling
#peivandpirouzi #training #canada #pirouzi #international #funding #immigrants #refugees #canada #immigration #education
“FUNCTIONAL FOODS: CLAIMS AND LABELING” -- AN OVERVIEW OF THE LAWMichael Swit
Presentation to the Regulatory Affairs Professionals Society (RAPS) & University of Southern California School of Pharmacy conference on Dietary Supplements & Supplemental Foods." November 2000, Pasadena, CA., covering:
♦ What is a Functional Food
♦ Claims under Nutritional Labeling and Educations Act (NLEA)
♦ FDAMA Claims
♦ FTC Advertising Regulation
The Difference Between Intended Use, Indications for Use, and Instructions fo...EMMAIntl
No matter what your product is, at some point in your regulatory journey you will need to appropriately determine your product’s intended use, indications for use, and instructions for use. For most people, these three items sound like they should mean the same thing, but for the FDA, they are all different. Your company must use these terms correctly because incorrect use of them could lead to issues with the FDA granting your device approval or clearance...
In late 2011, the FDA released a document addressing how the pharmaceutical industry can and should respond to requests about off-label drug usage. This POV provides more information about the guidance document, highlights the key issues, and offers use cases to consider in the digital realm.
FDA Device Software Regulation by NetZealous LLCJimmyGFlores
The exponential growth of software and its level of complexity and use have brought both advantages as well as challenges. While the advantage is the advancement and multiplicity of use in medical devices; the challenge relates to the regulatory aspect.
"Pharmacovigilance in Crisis: Drug Safety at a Crossroads, 2018".Rosmirella Cano Rojas
Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers.
The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine- learning to automate pharmacovigilance operations.
These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs.
Issue 39: Preventing pediatric medication errors | Joint Commission
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_39.htm?print=yes[9/20/2010 11:54:27 AM]
Sentinel Event Alert
April 11, 2008
Issue 39, April 11, 2008
Preventing pediatric medication errors
Errors associated with medications are believed to be the most common type of medical error and are a significant cause of
preventable adverse events. Experts agree that medication errors have the potential to cause harm within the pediatric
population at a higher rate than in the adult population. For example, medication dosing errors are more common in pediatrics
than adults because of weight-based dosing calculations, fractional dosing (e.g., mg vs. Gm), and the need for decimal points.
“Research shows that the potential for adverse drug events within the pediatric inpatient population is about three times as high
as among hospitalized adults,” (1) says Stu Levine, PharmD, informatics and pediatric specialist, Institute for Safe Medication
Practices, an organization which serves as a resource for information on how to improve medication practices. “For this reason,
health care providers must pay special attention to the specific challenges relating to the pediatric population.”
A new study—the first to develop and evaluate a trigger tool to detect adverse drug events in an inpatient pediatric population
—identified an 11.1 percent rate of adverse drug events in pediatric patients. This is far more than described in previous
studies. The study also showed that 22 percent of those adverse drug events were preventable, 17.8 percent could have been
identified earlier, and 16.8 percent could have been mitigated more effectively. (2)
Children are more prone to medication errors and resulting harm because of the following:
Most medications used in the care of children are formulated and packaged primarily for adults. Therefore, medications often
must be prepared in different volumes or concentrations within the health care setting before being administered to children.
The need to alter the original medication dosage requires a series of pediatric-specific calculations and tasks, each
significantly increasing the possibility of error.
Most health care settings are primarily built around the needs of adults. Many settings lack trained staff oriented to pediatric
care, pediatric care protocols and safeguards, and/or up-to-date and easily accessible pediatric reference materials, especially
with regard to medications. Emergency departments may be particularly risk-prone environments for children. (3)
Children—especially young, small and sick children—are usually less able to physiologically tolerate a medication error due to
still developing renal, immune and hepatic functions.
Many children, especially very young children, cannot communicate effectively to providers regarding any adverse effects that
medications may be causing.
During calendar years 2006-2007, USP’s ...
Biosimilars: Regulatory and Clinical ConsiderationsCovance
Other considerations for clinical studies are that the regulations are written with some flexibility, and although clinical studies have been required thus far, they are not mandated by the regulations. Perception from sponsors is that innovators make process changes all the time that impact structure and no clinical study is done because of good analytical characterization so why are biosimilars different? With solid analytical and functional data, we should continue to challenge regulators on the need for clinical studies.
RTC Perspectives, May 2012: Thank You, Star TrekRTC
This quarter, "Perspectives" focused on Star Trek and looked at the developments in culture, technology, medicine and even travel that we owe to this iconic series. Contributions come from the Dii, Account, Creative, Strategy, and PM teams at RTC, and original cover art is by Joshua Scott.
RTC POVs: Facebook Timeline for Pharma Brand Pages, April 2012RTC
Facebook has rolled out its Timeline feature for brand pages, and is offering more options than ever for brands to connect with their fans within the social network. However, there are implications for pharma that marketers must be aware of.
RTC POVs: FDA Guidance on TV Ad Pre-Dissemination ReviewRTC
In March 2012, the FDA released new guidelines for certain direct-to-consumer television ads. In this POV, Leigh Miller discusses RTC’s interpretation of the guidance as well as implications for broadcast media as a whole.
FDA Warning Letters: Dr. Reddy's Labs, January 2012RTC
The FDA recently released a warning letter to Dr. Reddy’s Laboratories’ for the HCP site for their product Fondaparinux. The website was cited for failing to prominently display the boxed warning in both the copy and navigation. This POV, from RTC's Digital Integration and Innovation team, gives more background on the FDA warning and discusses the implications for drug companies and marketers.
RTC's Dii team has created this overview of the various options that are available to patients looking for support in managing their health care. The landscape includes mobile apps, devices, websites, and more.
Social Gaming: Farmville is for n00bs. A look at gaming across platforms and the culture of gaming “societies”. Includes media and sponsorship opportunities for digitally innovative brands. David BenBassett, Intern, Summer 2010
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Kseniya Leshchenko: Shared development support service model as the way to make small projects with small budgets profitable for the company (UA)
Kyiv PMDay 2024 Summer
Website – www.pmday.org
Youtube – https://www.youtube.com/startuplviv
FB – https://www.facebook.com/pmdayconference
Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.
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The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
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RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
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What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
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We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
3. How you can capture more CRM data to understand your audience better through video testimonials. 📊
Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy.
Editable Toolkit to help you reuse our content: 700 Powerpoint slides | 35 Excel sheets | 84 minutes of Video training
This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com
Digital Transformation and IT Strategy Toolkit and Templates
FDA Warning Letter: Busulfex Site
1. FDA Warning: Busulfex Warned for Misleading Content on Website
Remy Wainfeld, Digital Integration & Innovation, RTCRM
November 2011
Top-Level Points Summary
On October 17, 2011, the FDA released a warning letter1 to Otsuka America
Otsuka received a warning letter
Pharmaceutical, Inc. (OAPI) regarding its health care professional website for
from the FDA because its
Busulfex, which is a black box drug for leukemia treatment. The FDA
Busulfex website omits and
concluded that the website violates compliance requirements by omission of
minimizes risk information and
safety information, minimization of risk information, unsubstantiated and
makes unsubstantiated and
misleading claims, and overstatements of efficacy across multiple pages.
misleading claims.
This warning letter indicates Key Information
that the FDA is more According to the FDA, the Busulfex website
aggressively examining aspects suggests that the drug is safer than has
of websites where marketing been demonstrated by research or clinical
language is used, including evidence. In particular, dosage and
headlines and taglines. administration for children is mentioned,
Many pages on the site omit but the site fails to convey all risk
information from the PI or make information and adverse events reported
claims contrary to information for children. Also, the Important Safety
from the PI, including a boxed Information (ISI) section at the bottom of
warning. each page and some interior content does
not include all facts regarding toxicity
The FDA letter says the Busulfex reported in the Prescribing Information (PI).
website draws inaccurate Lastly, specific pages related to dosing and
conclusions, misinterprets data administration fail to discuss the need to
from studies and employs take accompanying drugs prior to and
improper data calculation—all throughout the course of treatment.
information must comply with
the reporting standards The warning letter further states that the Busulfex website makes deceptive
established by the scientific claims regarding safety and efficacy. Several pages of the website claim “low
community. incidence of severe toxicities” contrary to the toxicity information contained
in a boxed warning. In addition, the site makes certain claims about the
usage of Busulfex for seizures, contrary to observations reported in the PI.
Likewise, the Busulfex website claims a “straightforward IV administration”
even though there are several instructions that must be followed to properly
administer the drug.
Moreover, the letter says the site overstates the efficacy of Busulfex by
reporting misleading statistics: The site mentions statistics about the
probability of overall survival and disease-free survival that have not been
accurately calculated in accordance with scientific methodologies.
The FDA also cites the Busulfex tagline “Begin With Precision,” as well as
numerous examples of claims and webpage headlines that use words like
“precision,” “optimal,” “predictable,” and “controlled,” as being misleading.
These claims imply a correlation between the drug and certain clinical
benefits not supported by legitimate evidence. This is unusual, because
elements like the tagline would have already been through rigorous legal
review, and likely used on many other pieces of collateral.
1
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Enforceme
ntActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UC
M278157.pdf
2. FDA Warning: Busulfex Warned for Misleading Content on Website
Remy Wainfeld, Digital Integration & Innovation, RTCRM
November 2011
Implications and Action Items
This warning letter demonstrates the importance of making accurate and fully supported claims and associations on pharmaceutical
websites. As always the FDA is evaluating drug information for the most stringent accuracy, so it is best to:
Remember that all advertising language is subject to FDA surveillance. This warning letter cited multiple examples of
misleading language that appeared outside of the body copy in the webpage and section headlines, and in the website
tagline. While there exists only one other instance of a similar warning,2 marketers ought to bear in mind that this copy is
subject to the same level of scrutiny as the body copy and this letter may mark the start of stricter FDA surveillance. All
language that defines the brand identity and may appear across a variety of media and materials, such as the product
tagline, ought to be carefully selected.
Be consistent with the PI. All risk information reported in the PI ought to be reported on the website with accuracy and
without omission of facts regarding risk.
Ensure data is complete. Make sure that claims, associations and correlations between the drug and clinical outcomes are
accurate and backed by legitimate evidence and accepted scientific methodologies.
For more insights into applying FDA regulations to digital marketing, see: http://rtcrm.com/whitepapers/.
The RTCRM Digital Integration and Innovation team is tasked with keeping track and making sense of the ever-changing digital
world. It’s our job to understand the nuances of how and why different types of people use technology and what that tells us about
them. More importantly, it’s our job to help our clients apply this knowledge to better communicate with their customers. We help
clients translate business goals into marketing campaigns that build relationships with customers. In the 21st century, understanding
how and why someone uses technology is as important as understanding where they live, what gender they are, and how old they
are. That’s where we come in. From ensuring that technological behavior is considered in the research phase, to tactical plans that
align digital, print and broadcast tactics, we work with clients and internal partners to make sure it all works.
It’s not about what’s cool. It’s about what works.
2
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPhar
maceuticalCompanies/UCM260575.pdf
RTCrm Proprietary Pg. 2