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"Off-Label" and Investigational Use Of Marketed Drugs

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Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device

Actived: Wednesday Jul 11, 2018

Link: https://www.fda.gov/regulatoryinformation/guidances/ucm126486.htm

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

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FDA has been using its authority to regulate marketing and branding in conjunction with the prohibition on unapproved drugs to create what Cortez calls a “squeeze play” to regulate off-label promotion.

Actived: Wednesday Oct 18, 2017

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

Off-label Use: The Fine Line Between Illegal Promotion and

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BioWorld Online is the news service of record for the biotechnology industry and is updated every business morning. BioWorld Online will keep you up to date on all of the industry's business, science and regulatory news -- mergers and collaborations, FDA hearings and results, breakthroughs in research and much more.

Actived: Saturday Jan 19, 2019

Link: http://www.bioworld.com/content/label-use-fine-line-between-illegal-promotion-and-useful-information

Guidance for Industry - Food and Drug Administration

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off-label use are used interchangeably in this guidance to refer to a use of an approved or cleared medical product that is not included in the product's approved labeling or

Actived: Friday Jan 18, 2019

Link: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.pdf

List of off-label promotion pharmaceutical settlements

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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs.

Actived: Friday Jan 18, 2019

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

The FDA’s New Guidance for Off-Label Promotion Is Only a Start

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LEGAL STATUS OF OFF-LABEL PROMOTION. Off-label prescribing resides in a regulatory “no-man’s land.” The FDA’s approval of drugs is specific to the diagnosis or treatment of delineated symptoms, conditions, and diseases for which a drug is indicated.

Actived: Friday Sep 29, 2006

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2730097/

FDA Allows Off-Label Promotion, Sort of. - FDA MAP

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In two new Guidance documents released this week, FDA presents a detailed explanation of its requirements for advertisement of approved products.

Actived: Tuesday Jan 15, 2019

Link: https://www.fdamap.com/fda-allows-off-label-promotion-sort-of.html

FDA Sanctions Off-Label Drug Promotion | Health Affairs

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Physicians have the authority to prescribe drugs for any reason they believe will benefit the patient, regardless of whether the use is on- or off-label. Off-label prescription is neither illegal

Actived: Monday Jul 18, 2016

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

FDA Permitted Off-Label Promotion | The Regulatory

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FDA Permitted Off-Label Promotion of Regulated Products FDA recently released a couple of guidance documents updating its rules for promoting off-label uses of approved products in the light of FDA’s recent legal losses.

Actived: Friday Jan 18, 2019

Link: https://www.fdamap.com/fda-permitted-off-label-promotion-the-regulatory-paradigm.html

Off-label use - Wikipedia

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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.

Actived: Thursday Jan 17, 2019

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

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