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- The term "reprint carrier" refers to the folder or binder in which a reprint is inserted. The FDA has raised concerns about the use of reprint carriers, stating that they can be "false or misleading" if they present unsubstantiated superiority claims or overstate the efficacy of a product1. The guidance also allows for other firm-generated presentations, including digital or video media, as long as the reprint accompanies the presentation2.Learn more:✕This summary was generated using AI based on multiple online sources. To view the original source information, use the "Learn more" links.The reprint carrier — the folder or binder in which the reprint is inserted — was “false or misleading because it presents unsubstantiated superiority claims and overstates the efficacy of Taxotere,” according to the FDA.www.pharma-mkting.com/blog/distribution-of-reprin…From a practical perspective, the guidance blesses off-label “reprint carriers” as well as other firm-generated presentations, including digital, video or other media, if the reprint accompanies the presentation (e.g., presumably, via link or attachment).www.kslaw.com/news-and-insights/beyond-reprint…
Distribution of Reprints: Another Example of FDA Flexing Its ...
WEBMay 18, 2009 · The reprint carrier — the folder or binder in which the reprint is inserted — was “false or misleading because it presents unsubstantiated superiority claims and …
See results only from pharma-mkting.comPharma “Social Networks”: …
If you are a regular reader of Pharma Marketing Blog, you know that I …
From Good Reprint Practices to SIUU …
WEBNov 10, 2023 · Communications related to SIUU are called “SIUU Communications” and FDA uses the term “source publication” to refer to published reprints, CPGs, reference texts, or material from an …
WEBFederal statutes and FDA regula-tions prohibit manufacturers from promoting approved drugs or devices for unapproved uses, also known as “of-label” uses.2 In the past five …
Beyond Reprints for Scientific Information on Unapproved Uses of ...
WEBOct 25, 2023 · From a practical perspective, the guidance blesses off-label “reprint carriers” as well as other firm-generated presentations, including digital, video or other …
FDA Expands and Clarifies Its Good Reprint Practices Guidance
WEBMar 2, 2014 · As a result, last Friday, FDA issued a new Draft Guidance revising the 2009 document to expand FDA’s guidance on good reprint practices to apply to medical …
New FDA reads journal reprints differently - Fierce Pharma
WEBMay 14, 2009 · Poor Sanofi-Aventis got to be the guinea pig on this one: FDA cited the drugmaker for a reprint carrier that allegedly exaggerated the benefits of its breast …
FDA Issues Revised Draft Guidance on “Off-Label” …
WEBNov 2, 2023 · The addition of the second category is particularly significant because it recognizes that firms often develop presentations to accompany distributed reprints (e.g., “reprint carriers”).
FDA Draft Reprint Guidance - Epstein Becker & Green
WEBMar 5, 2008 · Although the Draft Reprint Guidance is not yet final, it presents a useful, albeit preliminary, reference for manufacturers assessing their current compliance efforts …
WEBThe Food and Drug Administration (FDA) has released updated recommendations for the distribution of scientific and medical publications (the New Reprint Guidance).1 In …
The Sunshine Act’s Crackdown on Medical Reprints—What …
WEBNov 18, 2013 · In an effort to create transparency between pharmaceutical companies and physicians, The Sunshine Act is significantly changing the exchange of medical reprints. …
WEBFDA has traditionally interpreted the Federal Food, Drug, and Cosmetic Act to give it authority to consider a company's dissemination of reprints of articles about …
Reprints guidance has strings attached - MM+M
WEBFeb 1, 2009 · Drug company reps can distribute–but not discuss–reprints of journal articles on off-label uses for drugs, according to an FDA guidance posted last month. …
Leverage the power and versatility of reprints | Wolters Kluwer
WEBDec 6, 2019 · Reprints provide independent and objective evidence to substantiate your marketing messages. Use them to achieve your marketing campaign’s goals.
WEBApplication Information – Provide the application type (New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), …
Publication Planning: The Science Behind it All | PharmaVoice
WEBJan 2, 2008 · Have a presence at those meetings and have reprint carriers made by the ad agency or the medical-education agency to give the reps something solid to talk …
Sanofi Gets Untitled Letter for Taxotere Journal Reprint Carrier
WEBThe reprint carrier made multiple superiority claims based on a study that did not meet its primary endpoint — statistically significant objective response rates for Taxotere …
FDA warning letter to Sanofi-Aventis re Taxotere marketing
WEBMay 14, 2009 · The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a professional reprint …
Reprint Carriers Rep Training Presentation Pages 1-8 - FlipHTML5
WEBJul 17, 2020 · Check Pages 1-8 of Reprint Carriers Rep Training Presentation in the flip PDF version. Reprint Carriers Rep Training Presentation was published by …
Welcome to the Clinical Nutrition Resource Library
WEBJun 17, 2021 · Reprint Carrier - Blaauw et al. 2019: Micronutrients in Adult Patients. View resource. Amino acids • Intensive care.
reprint carrier | English to French | Medical: Pharmaceuticals
WEBFeb 6, 2017 · The reprint carrier -- the folder or binder in which the reprint is inserted -- was "false or misleading because it presents unsubstantiated superiority claims and …
Russian Aircraft Intercepts Over 'NATO Lake' at Alarming Rate
WEB20 hours ago · 0. Russian military aircraft are being intercepted by NATO forces at an alarming rate over the Baltic Sea. A NATO official confirmed to Newsweek that about …
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