Off Label Promotion Fda

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Understanding Unapproved Use of Approved Drugs "Off Label ...

(20 days ago) Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is: Used for a disease or medical condition that it is not approved to treat, such as when ...

https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label

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FDA Issues Warning Letter for Off-Label Promotion of Drug ...

(2 days ago) The FDA requested that Nephron immediately cease such off-label promotion. In addition, Nephron was also directed to submit a plan to the FDA to correct the promotion of any unapproved use of its drug. If you need assistance understanding off-label promotion or FDA warning letters, please contact me.

https://druganddeviceblog.com/fda-issues-warning-letter-for-off-label-promotion-of-drug-to-treat-covid-19/

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Off-Label Drug Promotion | Health Affairs

(3 days ago) FDA regulation of off-label promotion Under FDA rules, any promotional materials distributed by a company should be truthful, balanced, nonmisleading, and supported by substantial evidence.

https://www.healthaffairs.org/do/10.1377/hpb20160630.920075/full/

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FDA releases new guidance on off-label promotion | Health ...

(3 days ago) FDA releases new guidance on off-label promotion ... Contextual information about adverse reactions associated with a product, for example, if the drug’s label lists nausea as a potential adverse reaction and that the drug can be taken with or without food, a CFL communication might provide information about how taking the drug with food ...

https://www.thehealthlawpulse.com/2018/06/fda-releases-new-guidance-off-label-promotion/

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Off-Label Pharmaceutical Marketing and unlawful drug promotion

(2 days ago) Off-label marketing is the promotion of a drug or medication by manufacturers for a purpose other than what the Food and Drug Administration (FDA) has approved. This is one of the more high-profile and dangerous forms of pharmaceutical fraud, an illegal practice that has harmed thousands of people and defrauded Medicare and Medicaid of billions ...

https://www.whistleblowersinternational.com/types-of-fraud/pharmaceutical/off-label-marketing/

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Here’s how FDA officials think you can legally promote off ...

(2 days ago) The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save ...

https://www.medicaldesignandoutsourcing.com/heres-how-to-legally-promote-off-label-device-drug-uses/

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FDA's Authority to Regulate Off-Label Promotion | The ...

(6 days ago) The Federal Food, Drug, and Cosmetic Act (FDCA), which provides the overarching framework for pharmaceutical regulation in the United States, does not explicitly prohibit off-label promotion, but it permits FDA to regulate manufacturers’ marketing and branding of drugs and prohibit the introduction of new, unapproved drugs into the market.

https://www.theregreview.org/2017/10/18/whisenant-fda-off-label-promotion/

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List of off-label promotion pharmaceutical settlements ...

(9 days ago) The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...

https://en.wikipedia.org/wiki/List_of_off-label_promotion_pharmaceutical_settlements

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Off-Label Pharmaceutical Marketing: How to Recognize and ...

(2 days ago) Off-Label Promotion and the False Claims Act. Unlawful off-label drug promotion has been the subject of significant health care fraud enforcement efforts by the United States Department of Justice (DOJ) and the States’ attorneys general using the Federal False Claims Act (FCA).

https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/off-label-marketing-factsheet.pdf

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Advertising and Promotion Guidances | FDA

(17 days ago) FDA guidance documents regarding advertising and promotion. FDA guidance documents regarding advertising and promotion. ... Responding to Unsolicited Requests for Off-Label Information About ...

https://www.fda.gov/animal-veterinary/guidance-industry/advertising-and-promotion-guidances

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On Promoting Off-Label Use | Drug & Device Law

(8 days ago) We’ve posted more times than we can count in support of the position that FDA-regulated manufacturers should be able to engage in truthful “promotion” of the off-label uses of their products. Well, on nationwide TV – and in the presence of the Commissioner of the FDA – on March 19, 2010 the President of the United States promoted the off-label use of a prescription drug ...

https://www.druganddevicelawblog.com/2020/03/on-promoting-off-label-use.html

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FDA Sanctions Off-Label Drug Promotion | Health Affairs

(2 days ago) The settlement does not extend to Amarin, or other drug companies, a carte blanche for off-label promotion, but it may provide guidance on FDA thinking on this issue, and serve as a template for ...

https://www.healthaffairs.org/do/10.1377/hblog20160719.055881/full/

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Off-Label Drug Use and the First Amendment

(3 days ago) The U.S. Second Circuit Court of Appeals determined that federal law does not prohibit "the truthful off-label promotion of FDA-approved prescription drugs," so as long as drug companies do not lie to or mislead healthcare providers, such promotion is protected commercial speech under the First Amendment.

https://blogs.findlaw.com/injured/2017/10/off-label-drug-use-and-the-first-amendment.html

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FDA Off-Label Prescription Drug Promotions

(7 days ago) When they do, it is referred to as an “off-label” promotion. This has become a significant problem since 1985 when the FDA began allowing direct-to-consumer (DTC) advertising of drugs, which is very popular today. In 2015, spending on DTC ads in the US reached $5.6 billion.

https://www.levinlaw.com/fda-off-label-promotion

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Origins of the prohibition against off-label promotion

(20 days ago) The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penalties for such "off-label" promotion. The statutory interpretati …

https://pubmed.ncbi.nlm.nih.gov/25163210/

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Guidance for Industry - Food and Drug Administration

(1 months ago) 54 ; in the product's statement of intended uses). FDA recognizes that these off-label uses or treatment : 55 ; regimens may be important therapeutic options and may even constitute a medically ...

https://www.fda.gov/media/82660/download

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On Promoting Off-Label Use II | Drug & Device Law

(3 days ago) Not too long ago we commented on the President of the United States promoting the unproven off-label use of a prescription drug, hydroxychloroquine, for treatment of COVID-19, on nationwide TV, in the presence of the Commissioner of the FDA, no less. As we pointed out in the prior post, this drug has serious potential side effects – life threatening cardiovascular disorders.

https://www.druganddevicelawblog.com/2020/04/on-promoting-off-label-use-ii.html

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Off-Label Discussion Before and During Clinical Trials ...

(6 days ago) So if there was other evidence of off-label promotion, the off-label dissemination activities would be considered part of the totality of the evidence FDA would look at in pursuing enforcement. As noted above, when section 401 sunset, FDA was unsure of what to do with off-label dissemination in this apparent legislative and regulatory void.

http://www.duvalfdalaw.com/news/articles/fda-news/Off-Label-Discussion-Before-and-During-Clinical-Trials

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FDA Off-Label Promotion Guidelines - Webinar Compliance

(1 days ago) FDA Off-Label Promotion Guidelines . Product Id : FDB2713; ... It is imperative that firms stay in compliance with the FDA’s policy on how to communicate off-label uses of the FDA-approved or cleared medical products (drugs or devices) with the health care professionals.

https://www.webinar-compliance.com/product/fda-off-label-promotion-guidelines-david-lim-fdb2713/

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"Off-Label" and Investigational Use Of Marketed Drugs ...

(1 year ago) INFORMATION SHEET "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices Guidance for Institutional Review Boards and Clinical Investigators January 1998

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices

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FDA Regulation Of Off-Label Promotion: An Answer

(6 days ago) to involve off-label promotion but in actual fact involve the permitted non-promotional distribution of off-label information. The FDA recognizes that the public health is actually served by a certain amount of manufacturer distribution of information about off-label uses. As a result, there have

https://www.sidley.com/~/media/Files/Publications/2012/02/FDA%20Regulation%20Of%20OffLabel%20Promotion%20An%20Answer/Files/View%20Article/FileAttachment/SSRNid2000329

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Don't Fix What Ain't Broken--Off-Label Marketing, the FDA ...

(15 days ago) The FDA considers the promotion of a drug or device for a use other than one that has been approved by the FDA—what is known as “off-label” promotion—to violate the misbranding proscriptions because when a drug or device is promoted for an unapproved use, the label contains no instructions about how to safely use the drug for the ...

https://law.emory.edu/ecgar/content/volume-5/issue-1/essays/off-label-marketing-fda-regime-first-amendment.html

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FDA Surrenders in Off-Label Promotion Fight | Orthopedics ...

(5 days ago) Recently, a federal jury acquitted Vascular Solutions and its CEO Howard Root of charges of off-label promotion of that company’s device for the treatment of varicose veins. In that case, the jury received instructions from the judge stating that truthful speech is a defense to FDA violations.

https://ryortho.com/breaking/fda-surrenders-in-off-label-promotion-fight/

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Warning Letters 2019 | FDA

(16 days ago) These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion and CDER Headquarters Warning Letters.

https://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/warning-letters-2019

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Compounding the Off-Label Promotion Debate: How FDA Could ...

(2 days ago) Compounding the Off-Label Promotion Debate: How FDA Could Regulate the Promotion of Unapproved Drugs. by Eli Tomar. As attention on the off-label promotion of prescription drugs intensifies, it is worth examining how this evolving regulatory landscape applies to the promotion of other prescription drugs that have not been deemed safe and effective by the Food and Drug Administration (FDA) for ...

https://www.fdli.org/2017/10/compounding-off-label-promotion-debate-fda-regulate-promotion-unapproved-drugs/

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Off-label use - Wikipedia

(4 days ago) Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.. Off-label use is generally legal unless it violates ethical guidelines or safety regulations.

https://en.wikipedia.org/wiki/Off-label_use

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About Product Intended Use, Label and Off-Label Promotion ...

(2 days ago) In this week’s blog, we will provide some basic clarification regarding product intended use, label and off-label promotion and their limitations. These issues are covered in many separate guideline documents and regulations issued by the FDA and other agencies (e.g. EMA).

https://bioregservices.com/blog/product-intended-use-label-off-label-promotion-medical-device-drugs/

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Off–Label Promotion Or Scientific Exchange? A Multimillion ...

(2 days ago) The FDA historically has held the view that off-label promotion of a device, or any medical product, is misbranding under the Food, Drug, & Cosmetics Act. Other federal laws 4 and agency guidances 5 address off-label promotion, but FDA never explicitly defines what constitutes scientific exchange, ...

https://www.meddeviceonline.com/doc/off-label-promotion-or-scientific-exchange-a-multimillion-dollar-question-0001

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Off-Label Promotion by Manufacturers FDA Modifies Rules ...

(2 days ago) FDA enforcement officials would have to reach a higher standard of evidence for accusing a manufacturer for off-label promotion. This week FDA released a new rule describing a wholistic approach to assess the intent of a manufacturer to promote new uses of a previous-approved product thereby creating flexibility in enforcement of marketing ...

https://www.fdamap.com/off-label-promotion-by-manufacturers-fda-modifies-rules-for-enforcement.html

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Off-Label Promotion of Medical Devices: Seeking Clues from ...

(9 days ago) In one instance, FDA issued a warning letter to a company alleging off-label promotion of its drug. According to the Warning Letter, the challenged activity stemmed from a presentation to a committee within the Maryland Department of Health and Mental Hygiene to support the inclusion of the drug on the state's Preferred Drug List.

https://www.mastercontrol.com/gxp-lifeline/off_label_promotion_enforcement_0409/

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Shifts in the FDA’s Approach to Off-Label Promotion ...

(4 days ago) In contrast, a manufacturer engaging in off-label promotion is encouraging the off-label use of a product. Off-label promotion is said to violate the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the law that authorizes the FDA to regulate drug promotion by pharmaceutical companies.

https://clarivate.com/cortellis/article/shifts-in-the-fdas-approach-to-off-label-promotion/

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FDA Meeting - Off-Label Use of Medical Products - NWHN

(2 days ago) FDA defines off-label use of drugs as “use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labeling,” and currently prohibits off-label promotion of drugs and medical devices. Off-label communication may mean many things, including manufacturer-physician communication, direct-to ...

https://www.nwhn.org/fda-meetingofflabeluseofmedicalproducts/

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What is Off-Label Drug Use, and How Does It Affect You ...

(2 days ago) Problematic Off-Label Drug Use. In most cases, off-label drug use provides more benefit than risk, but it does occasionally cause problems. In the past, large drug manufacturers have been fined by the Justice Department for intentionally marketing their drugs for off-label use, exposing patients and doctors to undue risk.

https://www.consumersafety.org/news/what-is-off-label-drug-use/

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off-label promotion | FDA Compliance Made Easy

(4 months ago) Enforcement, FDA, Labeling, off-label promotion, off-label use FDA On December 3, 2012, the U.S. Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales representative, finding that promotion of FDA-approved drugs for unapproved uses, in and of itself, does not constitute a violation of …

https://giannamore-law.com/tag/off-label-promotion/

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FDA’s New Off-Label Guidance: What it Says and What it ...

(2 days ago) FDA’s New Off-Label Guidance: What it Says and What it Leaves Unanswered ... The comment period for addressing the Guidance’s substantive impact on the promotion of off-label uses, and responding to both solicited and unsolicited requests for information, expired on March 29, 2012. Therefore, manufacturers should consider the following.

https://www.foxrothschild.com/publications/fda%e2%80%99s-new-off-label-guidance-what-it-says-and-what-it-leaves-unanswered/

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Off-Label Promotion: Weighing the Impact of Rulings ...

(3 months ago) Rather than state that the ads constituted promotion of an "off-label" use, the FDA characterized the advertisement as "misleading because it overstates Evista's benefits." In addition to Agency action, companies also must be cognizant of the implications dissemination of off-label information could have in the context of patient safety ...

https://corporate.findlaw.com/litigation-disputes/off-label-promotion-weighing-the-impact-of-rulings-setting-back.html

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Off Label Drug Promotion, Coming Soon? – Handbook of Lower ...

(1 days ago) Clinical Trial for Osteomyelitis – No FDA Guidance; U.S. Second Circuit Court of Appeals Rulling. Just this past week the U.S. Second Circuit Court of Appeals ruled to prohibit criminal prosecution for truthful off label promotion of drugs as a First Amendment right.

https://www.leinfections.com/antibiotics/off-label-drug-promotion-coming-soon/

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How to Comply with FDA's Off-Label Promotion Guidelines ...

(2 months ago) FDA guidance about off-label information management Pros and cons of common methods for off-label promotion Converting off-label to on-label information Do’s and don’ts of social media techniques in off-label promotion. Who will Benefit: Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies, Dietary supplement ...

https://www.webinar-compliance.com/product/how-to-comply-with-fdas-off-label-promotion-guidelines/

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6-Hour Virtual Seminar on FDA Scrutiny of Promotion and ...

(21 hours ago) If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances.

https://www.gcplearning.com/virtual-seminar/6-hour-virtual-seminar-on-fda-scrutiny-of-promotion-and-advertising-practices--11583LIVE?Casper-Uldriks

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Off-Label Prescription Drugs Use: Benefits and Risks

(3 days ago) Greater promotion of off-label drug uses could have patients reaching deeper into their pockets to cover prescription costs. Health insurance companies closely scrutinize drugs that are used off ...

https://www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know

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AdvaMed Guiding Principles for Product Communications

(2 months ago) RESTRICTIONS ON OFF-LABEL PROMOTION The FDA regulates the labeling and promotion of medical devices and diagnostics (“products”) in the United States. Under FDA regulations and enforcement policies, these products may only be labeled (including promotional labeling) and advertised in a manner consistent with FDA approved or cleared uses ...

https://www.advamed.org/sites/default/files/resource/733_advamed_guiding_principles_for_product_communications_final.pdf

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Off-Label Promotion Is Free Speech - U.S. Pharmacist

(6 days ago) As off-label drug use itself is not prohibited, it does not follow that prohibiting the truthful promotion of off-label drug usage by a particular class of speakers would directly further the government’s goals of preserving the efficacy and integrity of the FDA’s drug approval process and reducing patient exposure to unsafe and ineffective ...

https://www.uspharmacist.com/article/off-label-promotion-is-free-speech

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FDA Regulation of Medical Device Advertising and Promotion

(1 days ago) Updated 2018. There are tens of thousands of medical devices being advertised and promoted in the U.S. The Food and Drug Administration (FDA) has statutory authority to regulate the advertising and promotion of “restricted” medical devices as well as any medical devices that are not authorized by FDA for sale or distribution for their intended use.

https://www.corporatecomplianceinsights.com/fda-regulation-of-medical-device-advertising-and-promotion/

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Fda Off Label Promotion - Find Coupon Codes

(2 months ago) Off-Label Pharmaceutical Marketing and unlawful drug promotion. CODES (10 days ago) Off-label marketing is the promotion of a drug or medication by manufacturers for a purpose other than what the Food and Drug Administration (FDA) has approved. This is one of the more high-profile and dangerous forms of pharmaceutical fraud, an illegal practice that has harmed thousands of people and defrauded ...

https://www.find-coupon-codes.com/fda-off-label-promotion/

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Caronia, Off-Label Promotion, And The First Amendment ...

(5 days ago) We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs. Id. (emphasis added). Although it’s by no means 100% sure, it looks like Caronia ’s narrowing interpretation (the court invoked a legal doctrine of construing a statute narrowly to ...

https://www.druganddevicelawblog.com/2012/12/caronia-off-label-promotion-and-firs.html

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Overview | Food and Drug Law | Epstein Becker & Green

(6 days ago) Developing policies, procedures, and strategy pertaining to FDA compliance, including product recalls (e.g., standards and processes for initiating recalls) and promotional practices (e.g., permissible claims and off-label promotion issues) Drafting responses to FDA-483s, Untitled Letters, and Warning Letters as they relate to various ...

https://www.ebglaw.com/food-and-drug-law/

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Amarin Wins Preliminary Injunction Against FDA To Promote ...

(14 days ago) A manufacturer that engages in non-communicative activities to promote off-label use cannot use the First Amendment as a shield.” The court also noted that “there is practical wisdom to much of the FDA’s guidance, including that a manufacturer vet and script in advance its statements about a drug’s off-label use.”

https://www.policymed.com/2015/08/on-friday-a-new-york-federal-judge-ruled-that-amarin-pharma-is-allowed-to-promote-vascepa-the-companys-omega-3-product-u.html

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Regulatory Focus on Off-Label Promotion Is Rising

(2 months ago) In 1999, the government settled one of the first off-label promotion cases with a drug company for $50 million. Since then, the DOJ’s efforts have continued unabated and the dollar amounts have grown significantly:[8] May 2004: $430 million off-label settlement to resolve criminal and civil liabilities related to a synthetic human growth hormone.

https://pharmaceuticalcommerce.com/legal-regulatory/regulatory-focus-on-off-label-promotion-is-rising/

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January 2019: Off-Label Promotion After Caronia: Proceed ...

(5 months ago) Truthful, non-misleading off-label promotion can also be proof of misbranding, the FDA has argued, if it demonstrates that a drug is being sold for an unapproved intended use – another form of ...

https://www.jdsupra.com/legalnews/january-2019-off-label-promotion-after-82651/

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