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* The AdvaMed Code
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FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
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Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Direct-to-Consumer AdsMichael 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.
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Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
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August 17, 2006 presentation to the IVT Medical Device Conference in San Francisco, CA, focusing on:
* Basics of the Law
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* Off Label Promotion & the First Amendment
* Other Legal Concerns Impacting Advertising
* The AdvaMed Code
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RTC POVs: FDA Guidance on TV Ad Pre-Dissemination ReviewRTC
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FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
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Learn about the 7 drivers of pharmaceutical television advertising. Television advertising for prescription drugs is a controversial practice but is an important component of the marketing strategy for many pharmaceutical manufacturers plus other healthcare product manufacturers. The FDA’s Center for Drug Evaluation and Research (CDER) and its Office of Prescription Drug Promotion(OPDG) closely monitor what pharmaceutical companies display and communicate within their television, print, radio or digital ads.
Get the complete insights through this article from Bare Sky Marketing Healthcare Content Writing Services
TGA presentation: Advertising therapeutic goods to consumers - Complying with...TGA Australia
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Authors:
Harvard-MIT Division of Health Sciences and Technology HST.535: Principles and Practice of Tissue Engineering Instructors: Myron Spector
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Harvard Medical School Brigham and Women's Hospital VA Boston Healthcare
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
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Devices Sponsor Information Day: 5 - Post-market - Advertising therapeutic go...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
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Learn about the 7 drivers of pharmaceutical television advertising. Television advertising for prescription drugs is a controversial practice but is an important component of the marketing strategy for many pharmaceutical manufacturers plus other healthcare product manufacturers. The FDA’s Center for Drug Evaluation and Research (CDER) and its Office of Prescription Drug Promotion(OPDG) closely monitor what pharmaceutical companies display and communicate within their television, print, radio or digital ads.
Get the complete insights through this article from Bare Sky Marketing Healthcare Content Writing Services
TGA presentation: Advertising therapeutic goods to consumers - Complying with...TGA Australia
An overview of the legislative framework that the TGA administers to regulate the advertising of therapeutic goods, including an exploration of key concepts, such as why advertising is regulated, the definition of ‘advertise’, food-medicine and cosmetic-medicine interface issues, prohibited representations and restricted representations.
Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections.
Federal Regulatory Issues Us Food And Drug Administration Medical Device Amen...Jacobe2008
Authors:
Harvard-MIT Division of Health Sciences and Technology HST.535: Principles and Practice of Tissue Engineering Instructors: Myron Spector
Massachusetts Institute of Technology
Harvard Medical School Brigham and Women's Hospital VA Boston Healthcare
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided, along with information about the enforcement discretion policy the TGA will apply in 2019 for complaints about advertisements that do not comply with the Code.
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Presentation to the 2017 Regulatory Affairs Certification (RAC) Test Review Course sponsored by the San Diego Regulatory Affairs Network (SDRAN) in July 2017, with a focus on:
A Brief History of Combination Product Regulation
Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
The Request for Designation (RFD) Process
GMPs
Post-Market Safety Reporting
How Many Applications to File?
User Fees
Similar to FDA DTC Television Ad Review Program-The 45-Day Clock (20)
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http://goo.gl/XL0H4
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The iPad is more than an interactive e-reader or a seductive technology gimmick. It is a portable library that can connect instantly to new data and if used as it was designed, it can become a synergistic connection that can truly create the multi-dimensional dynamic experience used not only for detailing but also for teaching and interacting with patients.
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"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
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[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
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LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
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Know more: https://www.synapseindia.com/technology/mean-stack-development-company.html
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What might I learn?
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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.
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
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FDA DTC Television Ad Review Program-The 45-Day Clock
1. The FDAAA DTC Television Ad
Pre-Dissemination Review Program
The 45-Day Clock
Krystina Smith, Research Analyst
Of course we aren’t your lawyers and our
lawyers are making us say to you that you
should check all this out with your own
lawyers. Full employment for lawyers . . .
2. The FDAAA was signed into law in September 2007
• The Food and Drug Administration Amendments Act of 2007 (FDAAA)
gives the FDA the authority to “… require the submission of any
television advertisement for a drug … not later than 45 days before
dissemination of the television advertisement”
• The FDA may make recommendations with respect to information
included in the label of the drug on:
– Changes that are necessary to protect the consumer good and well-being, or that are
consistent with prescribing information for the product under review
– Statements for inclusion in the advertisement to address the specific efficacy of the
drug as it relates to specific population groups, including elderly
populations, children, and racial and ethnic minorities, if appropriate and if such
information exists
Source:
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDC
Act/FoodandDrugAdministrationAmendmentsActof2007/default.htm
3. The FDA has just acted on this
AUTHORITY
and is now implementing a
“45-day clock”
4. Sponsors are required to submit TV ads for pre-dissemination
review in 6 categories
Category Definition
The initial TV ad for any prescription drug or the initial TV ad for a new or expanded
Category 1
approved indication for any prescription drug
All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy
Category 2
(REMS) with elements to assure safe use
Category 3 All TV ads for Schedule II controlled substances
The first TV ad for a prescription drug following a safety labeling update that affects
Category 4 the Boxed Warning, Contraindications, or Warnings and Precautions section of its
labeling
The first TV ad for a prescription drug following the receipt by the sponsor of an
enforcement letter (ie, a warning or untitled letter) for that product that either cites a
Category 5
TV ad or causes a TV ad to be discontinued because the TV ad contained violations
similar to the ones cited in the enforcement letter
Any TV ad that is otherwise identified by the FDA as subject to the pre-dissemination
Category 6
review provision
Source:
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDC
Act/FoodandDrugAdministrationAmendmentsActof2007/default.htm
5. Noncompliance with the FDAAA has significant consequences
• It is prohibited to disseminate a TV ad that falls within 1 of the 6
categories:
– That has not been submitted for review
– Before the 45-day comment period ends, without waiting for comments from the FDA
– That has not incorporated the agency’s comments
• Noncompliance can result in criminal penalties, a civil monetary
penalty amount, the issuance of an untitled letter, a notice of violation,
warning letter, or other government enforcement action to/against the
sponsor of the TV ad
Source:
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosm
eticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministration
AmendmentsActof2007/default.htm
6. What if the FDA does not respond within the “45 day clock”?
• If the FDA is not able to provide comments within the 45 calendar day
time frame, the FDA will notify the sponsor
– The FDA notification WILL include an estimation of the date on which FDA expects to
provide its comments
• The sponsor is given 2 options
– Wait for FDA’s comments before disseminating the TV ad
– Disseminate the TV ad without waiting for FDA’s comments
• Whichever decision the sponsor makes, the FDA should be notified
• Once the 45-day review time has elapsed, there is no specific legal
consequence resulting from disseminating the TV ad
– However, the sponsor is still at risk of enforcement action if the ad violates the FD&C
Act and implementing FDA regulations
Source:
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosm
eticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministration
AmendmentsActof2007/default.htm
7. The FDAAA pre-dissemination review program is specifically
for television ads
• The FDA issued the guidance to communicate the categories of
TV ads for a particular drug or group of drugs
• There is no guidance for videos uploaded to the Internet
?
8. There may be consequences for DTC ads being placed
on the Internet that are not presubmitted to FDA
• Once online, it is possible to embed the
video on other websites or promote it
via social media platforms, such as
Twitter, which both could exacerbate
any potential FDA concerns
• Although not a direct violation of the
evolved guidance, the FDA can still cite
the uploaded video as violative
9. Smart social media engagement does not need to rely on
FDA “loopholes”
• The line between TV and online videos
will continue to blur
• The potential of online videos is powerful
and should be respected as so
• A smart and engaging social media
strategy is possible for pharma
companies and can be managed within
FDA guidelines
• Following the spirit of the new guidelines
is recommended – even when
considering DTC ads for the Internet