The document summarizes new FDA draft guidelines for responding to unsolicited requests for off-label information on social media. It outlines that the guidelines cover unsolicited requests for off-label uses of approved products, but not requests about approved uses or pre-launch products. It also defines solicited vs. unsolicited requests and provides recommendations for how companies can respond to private vs. public unsolicited requests in a truthful, non-promotional manner according to the guidelines.
FDA’s Draft Guidance – Exploring the impact on compliance and operationsHuron Consulting Group
This session, "FDA's Draft Guidance - Exploring the impact on compliance and operations" was presented at the 10th Annual Pharmaceutical Compliance Congress, hosted by CBI.
Improving Global Health Through Online CommunityJon Michaeli
Sermo working closely with medical heroes from Floating Doctors, a non-profit relief organization, brings some of the best medical expertise in the U.S. straight to patients in developing countries.
The 17th edition of Social policy in the European Union: state of play reports on recent EU and national social policymaking, with contributions from leading scholars pointing to a ‘crisis’, the best word to characterize 2015. Tensions in the EU reached an unprecedented level: the migration crisis showed the EU the limits of its decision-making capacity, economic weakness continued to prevail, austerity policies and the badly handled socioeconomic Greek crisis turned populations against the EU – and then came the Brexit vote.
This book argues that the centrifugal pressures within the EU and the EMU can be handled through a process of managed integration and disintegration. It maintains that the EU’s renewed focus on long-term unemployment is biased towards a ‘jobs first’ approach, contributing to the EU’s Janus-faced approach to the social dimension. It demonstrates that the austerity dogma has led to an erosion of social rights and makes a plea in favour of going ‘back to basics’ with regard to worker’s protection. Reflection and down-to-earth debate on the long-term integration of both EU migrants and refugees is required.
The political reality of 2015 demonstrates that the EU project has been too narrowly focused on reciprocity, instead of solidarity. The harsh reality is that the European project can no longer be considered irreversible. The EU’s core values must therefore be reaffirmed with a view to creating a new common sense of purpose, including a more explicit commitment to equitable growth via a European Social Union.
Corporate Social Media Guidelines - Protecting Your Organization From Hidden ...Raul Colon
One wrong move can land you or your company into an unknown abyss. The lack of guidance from Social Media and non-existent controls can cost companies hundreds of thousands or even millions. The hidden risks of not understanding the many channels of Social Media are immeasurable. With a better understanding and some guidance on Social Media Patterns yourself and your company are going to be able to mitigate the arising risks.
FDA’s Draft Guidance – Exploring the impact on compliance and operationsHuron Consulting Group
This session, "FDA's Draft Guidance - Exploring the impact on compliance and operations" was presented at the 10th Annual Pharmaceutical Compliance Congress, hosted by CBI.
Improving Global Health Through Online CommunityJon Michaeli
Sermo working closely with medical heroes from Floating Doctors, a non-profit relief organization, brings some of the best medical expertise in the U.S. straight to patients in developing countries.
The 17th edition of Social policy in the European Union: state of play reports on recent EU and national social policymaking, with contributions from leading scholars pointing to a ‘crisis’, the best word to characterize 2015. Tensions in the EU reached an unprecedented level: the migration crisis showed the EU the limits of its decision-making capacity, economic weakness continued to prevail, austerity policies and the badly handled socioeconomic Greek crisis turned populations against the EU – and then came the Brexit vote.
This book argues that the centrifugal pressures within the EU and the EMU can be handled through a process of managed integration and disintegration. It maintains that the EU’s renewed focus on long-term unemployment is biased towards a ‘jobs first’ approach, contributing to the EU’s Janus-faced approach to the social dimension. It demonstrates that the austerity dogma has led to an erosion of social rights and makes a plea in favour of going ‘back to basics’ with regard to worker’s protection. Reflection and down-to-earth debate on the long-term integration of both EU migrants and refugees is required.
The political reality of 2015 demonstrates that the EU project has been too narrowly focused on reciprocity, instead of solidarity. The harsh reality is that the European project can no longer be considered irreversible. The EU’s core values must therefore be reaffirmed with a view to creating a new common sense of purpose, including a more explicit commitment to equitable growth via a European Social Union.
Corporate Social Media Guidelines - Protecting Your Organization From Hidden ...Raul Colon
One wrong move can land you or your company into an unknown abyss. The lack of guidance from Social Media and non-existent controls can cost companies hundreds of thousands or even millions. The hidden risks of not understanding the many channels of Social Media are immeasurable. With a better understanding and some guidance on Social Media Patterns yourself and your company are going to be able to mitigate the arising risks.
Presented by Heather Schoegler and Tamarah Brownlee of Parkview Health. Covers content including:
- Guidelines or Policy or Both?
- Crafting your Policy and Guidelines
- NLRB Insights
- Implementation Plan
- Employee Social Media Examples
- Future Issues
- Your Next Steps
The little black book of social media for businessKing Content
We’ve complied a nifty Slideshare that is like your little black book on everything you need to know about social media for businesses. We’ve covered best practices, tricks, tips and the most up to date changes on each channel. So, whether it’s on Twitter, LinkedIn, Facebook, Instagram or Snapchat, we’ll show you the most effective and efficient way of using the channel.
Visual Brand Guidelines to Manage Social Media AccountsOrigzo
Learn about social media design, content guideline, brand streamline in this visual based PPT. Creating coherent social media guidelines that make top quality content is important. It also lays emphasis on creating uniformity in all of your social media posts so that your brand impression is maintained throughout the web.
Furthermore, various social media branding guidelines are discussed that give valuable information for maintaining consistency in the social media posts.
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.
Healthcare marketers understand the value of social media, but may not feel prepared to participate in such a tightly regulated space. How can you join the conversation while protecting your organization? With these five documents, you can safely enter the world of social media while reducing your liability and maintaining a consistent company message.
Visit us at www.GreyMatterMarketing.com
Physician Social Networking Overview for Pharma - by Ozmosis March 2010Joel Selzer
As physicians across the world embrace social networks, pharmaceutical firms are beginning to explore new means of engagement. It examines overall trends in social media, how physicians are adopting social networks across the world, current physician needs, examples of pharma initiatives and opportunities for pharma/physician engagement in 2010.
This presentation is a condensed version of a more detailed overview I recently used for discussions with pharmaceutical firms in the U.S and abroad.
Finding a job in an industry you have no previous experience of is one of the hardest career challenges there is. Employers can demand that job candidates have prior experience in their industry because the market allows them to. You’ve got to be really up for the challenge if you’re going to succeed. It’s difficult, but it’s not impossible.
Presented by Heather Schoegler and Tamarah Brownlee of Parkview Health. Covers content including:
- Guidelines or Policy or Both?
- Crafting your Policy and Guidelines
- NLRB Insights
- Implementation Plan
- Employee Social Media Examples
- Future Issues
- Your Next Steps
The little black book of social media for businessKing Content
We’ve complied a nifty Slideshare that is like your little black book on everything you need to know about social media for businesses. We’ve covered best practices, tricks, tips and the most up to date changes on each channel. So, whether it’s on Twitter, LinkedIn, Facebook, Instagram or Snapchat, we’ll show you the most effective and efficient way of using the channel.
Visual Brand Guidelines to Manage Social Media AccountsOrigzo
Learn about social media design, content guideline, brand streamline in this visual based PPT. Creating coherent social media guidelines that make top quality content is important. It also lays emphasis on creating uniformity in all of your social media posts so that your brand impression is maintained throughout the web.
Furthermore, various social media branding guidelines are discussed that give valuable information for maintaining consistency in the social media posts.
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.
Healthcare marketers understand the value of social media, but may not feel prepared to participate in such a tightly regulated space. How can you join the conversation while protecting your organization? With these five documents, you can safely enter the world of social media while reducing your liability and maintaining a consistent company message.
Visit us at www.GreyMatterMarketing.com
Physician Social Networking Overview for Pharma - by Ozmosis March 2010Joel Selzer
As physicians across the world embrace social networks, pharmaceutical firms are beginning to explore new means of engagement. It examines overall trends in social media, how physicians are adopting social networks across the world, current physician needs, examples of pharma initiatives and opportunities for pharma/physician engagement in 2010.
This presentation is a condensed version of a more detailed overview I recently used for discussions with pharmaceutical firms in the U.S and abroad.
Finding a job in an industry you have no previous experience of is one of the hardest career challenges there is. Employers can demand that job candidates have prior experience in their industry because the market allows them to. You’ve got to be really up for the challenge if you’re going to succeed. It’s difficult, but it’s not impossible.
Regulatory & Quality Considerations in Virtual Drug DevelopmentMichael Swit
Presentation to Strategies for Success in Virtual Drug Development Conference on April 15, 2013, in San Diego, focusing on:
• General Considerations
• Why Quality & Regulatory Matter
• What Problems to Look For
• How to Find Problems
• Special Considerations
The Small Company Clinical Study Sponsor -- Roles & Duties Vis-à-vis LiabilityMichael Swit
September 24, 2014 presentation to the Outsourcing in Clinical Trials: Southern California Conference, sponsored by Arena Conferences, focusing on:
* Clarifying exactly what you are responsible for and what you made be held accountable for
* Analyzing degrees of liability between bigger and smaller companies
* Ensuring that you are enforcing compliance from your outsourcing partners to avoid repercussions on yourselves
* Determining aspects of your trial management that you should retain in-house as a minimum so as to avoid liability issues
* Explaining to funders why quality and risk-assessments are a necessary expenditure above the cheapest options
5 ways innovative brands leverage social data insights (1)Cision
The social intelligence space is evolving rapidly. Will you stay ahead of your competitors and industry trends? Learn the intelligent approach communicators take to harness the power of social data to inform business strategy. Members of the Visible Technologies team show how to beat competitors with the latest social intelligence trends, reduce research spend, and move beyond standard social metrics.
How to Convert Unknown Consumers into Patients Using Social MediaPerficient, Inc.
While patient engagement has been historically low, healthcare is transforming into a consumer-based industry. To meet these challenges, healthcare organizations need to rethink consumer engagement. Join us as we use real patient stories to help you:
Demonstrate a trusted and authentic voice using many-to-many digital communication tools
Identify important target markets and their preferred communication style
Attract unknown consumers to your organization's digital front door using content and social media
Understand the four important online conversion tools that transform unknown consumers
Influence behavior to improve consumer health and drive down costs
Why Compliance is a Tough Pill to Swallow – NutraceuticalsAffiliate Summit
This presentation is from Affiliate Summit West 2014 (January 12-14, 2014 in Las Vegas, NV). Session description: Discussion of strategies for manufacturers and marketers of nutraceuticals to avoid both FTC and FDA scrutiny, as well as recent FDA warning letters and trending enforcement tactics.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Surat @ℂall @Girls ꧁❤8527049040❤꧂@ℂall @Girls Service Vip Top Model Safe
FDA Guidelines for Social Media in Pharma
1. FDA Guidelines for Social Media
Rich Westelman, SVP-Sales & Client Services
February, 2012
2. The New Draft Guidelines: Sources
• Draft Guidance published December 2011; not intended to be
comprehensive; not the definitive ‘10 Commandments’ of
what’s allowed in social media
• Focus: Responding to Unsolicited Requests for Off-Label
Information
• Access the full document here:
– http://www.fda.gov/downloads/Drugs/Guidance
• Here are some other helpful blogs sites
– http://www.doseofdigital.com/2012/01/
– http://www.policymed.com/2012/01/fda-guidance
– http://www.pharmacompliancemonitor.com/asked-answered
2 2012 Confidential
3. The New Draft Guidelines: What is Covered?
• Requests for information about approved, cleared
indications/conditions of use for an approved FDA-
regulated product?
NOT COVERED
• Requests for information about products not yet
approved for any uses (i.e., pre-launch)?
NOT COVERED
• Requests for information about off-label uses of a
product currently on the market?
COVERED
3 2012 Confidential
4. What is Covered?
PRIVATE PUBLIC
An unsolicited request for An unsolicited request for
off-label information directed off-label information made in
privately to a pharma a public forum, whether
UNSOLICITED company using a one-to-one directed to a pharma
communication approach company itself or to a forum
(phone call, e-mail, written at large. Includes “emerging
letter, etc.) electronic media.”
SOLICITED Not covered by this guidance
4 2012 Confidential
5. The New Draft Guidelines: Definitions
• Solicited vs Unsolicited?
– You can’t separate the term “solicited …” from the rest
of the phrase “… request for off-label information”… do
not read solicited and equate with sponsored or paid
for
– The examples of solicited provided in the guidance all
reflect clear intent by the pharma company to
encourage or ask for examples of off-label usage
– Therefore: sponsored, public on-label content
published by pharma companies can yield “unsolicited
requests for off-label information”
5 2012 Confidential
6. Private Requests: Responses
PRIVATE PUBLIC
• To the Individual Only
• Answer only the specific question
• Truthful, non-misleading,
accurate & balanced
• Scientific in nature
• Should come from medical or
scientific personnel not sales or
marketing
• Include the standard materials,
including FDA-approved labeling,
actual indication disclosure, ISI,
references, etc.
• Maintain records re: nature of
request, requestor personal data,
what was provided, dates, etc.
• Nothing published in public, even if
the requesting individual references a
public forum in his private request
6 2012 Confidential
7. Public Requests: Context for Responses
• Pharma companies are the most knowledgeable and best
equipped to respond
– “Because firms usually have robust and current information about their products, it
can be in the best interest of public health for a firm to respond to unsolicited
requests for information about off-label uses of the firm’s products that are made in
public forums, especially since other responders may not provide or have access
to the most accurate and up-to-date medical product information
• Your responses are not to be posted in the public forum
– “Regardless of the fact that the original, unsolicited off-label question may have
been available to a very broad audience, the firm should not make its detailed
response with off-label information publicly available within the same forum.”
• So … responses will have a public reply acknowledging
the request was made and could have a private
component (direct communication with the requestor if he/
she follows up directly)
7 2012 Confidential
8. Public Requests: Responses
PRIVATE PUBLIC
• To the Individual Only • Published on the Public Forum
• Answer only the specific question • Only reference that the question
• Truthful, non-misleading, pertains to unapproved/
accurate & balanced uncleared use
• Scientific in nature • Encourage requestor to contact
• Should come from medical or the firm, and provide medical/
scientific personnel not sales or scientific rep contact information
marketing • Disclose identity and role of the
• Include the standard materials, person providing the response
including FDA-approved labeling, • Provide link to FDA-approved
actual indication disclosure, ISI, labeling
references, etc. • No promotional info or link to any
• Maintain records re: nature of promotional sources
request, requestor personal data, • If/when the requestor then contacts
what was provided, dates, etc. the firm, follow the recommendations
• Nothing published in public, even if as provided for under Private
the requesting individual references a Unsolicited requests
public forum in his private request
8 2012 Confidential
9. Sermo Products: Physician & Client Posts
PRIVATE PUBLIC
Sermo considers requests
for off-label info made in
both Physician Posts
UNSOLICITED (organic Sermo traffic) and
as comments within Client
Posts to be examples of
Public Unsolicited requests
SOLICITED Not covered by this guidance
9 2012 Confidential
10. Sermo Makes Compliance Easy
• For requests for off-label information made in the
comment section of Client Posts, we believe the client is
obligated to respond according to the guidelines
• Sermo provides a customized response that appears
immediately following the request; this remains in place
forever, documenting the mfgr’s proper response
This comment/question pertains to an unapproved use of _____.
Please contact Rebecca Jones in Medical Affairs at PharmaCo,
Inc. at (561) 443-8510 or rjones@medaffairs.pharmaco.com to
request additional information
10 2012 Confidential