Fda Off Label Promotion

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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: Sunday Mar 17, 2019

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

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 Mar 15, 2019

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

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: Saturday Mar 16, 2019

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

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 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: Tuesday Mar 19, 2019

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

About Product Intended Use, Label and Off-Label Promotion

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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).

Actived: Monday Mar 18, 2019

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

Off-Label Drug Information - ncbi.nlm.nih.gov

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The History of FDA Regulations Regarding Off-Label Promotion. The Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938 gave the FDA the authority to regulate drug promotion by pharmaceutical companies.

Actived: Monday Jan 12, 2009

Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2799128/

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: Monday Mar 18, 2019

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

"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

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