Statement of benefit-risk ratio assesment for substantiality
Spanish translation: declaración de la evaluación de la relación riesgo-beneficio para respaldar las reivindicaciones
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| 14:56 Oct 5, 2020 |
| English to Spanish translations [PRO] Medical - Medical: Pharmaceuticals / Update of Invetigator Brochure | |||||||
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|  Selected response from: Neil Ashby Spain Local time: 08:10 | ||||||
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Answers
11 mins confidence: 
Informe de evaluación comparativa de la relación riesgo-beneficio Explanation: Lo expresaría así en función del contexto. |
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41 mins confidence: peer agreement (net): +4
peer agreement (net): +4| statement of benefit-risk ratio assesment for substantiality declaración de la evaluación de la relación riesgo-beneficio para respaldar las reivindicaciones Explanation: declaración de la evaluación de la relación riesgo-beneficio para respaldar las reivindicaciones Could it be talking about substantiating product claims? If it is a cosmetic product or a nonprescription "remedy", I think this could on the right lines. -------------------------------------------------- Note added at 50 mins (2020-10-05 15:46:37 GMT) -------------------------------------------------- Here's the FDA's definition: Substantial Evidence (Substantiation) Substantial evidence refers to the data needed to support claims about an advertised drug. Before the FDA approves a drug for marketing, drug companies must complete studies to show that the drug does what they say it does. These studies are also required to support advertising claims about the drug. Drug companies need to have at least two studies to support these claims. https://www.fda.gov/drugs/prescription-drug-advertising/drug... Cosmetics Claims Substantiation: What You Need to Know The claims you put on your cosmetic product’s packaging must be substantiated. Even where cosmetics claims substantiation isn’t required by law, it’s a responsible business practice to put your cosmetic products through appropriate testing before they hit the market. https://www.bioalternatives.com/en/cosmetics-claims-substant... Four Basic Rules of Cosmetic Claim Substantiation http://www.scientificspectator.com/documents/personal care s... It also applies to medical devices and healthcare services/products: For claims involving healthcare services or products, those claims must be substantiated by competent and reliable evidence. https://cohenhealthcarelaw.com/fda-ftc-law/advertising-and-m... Nutrients and foods: It is important to consider whether or not the health claim proposed is based on the essentiality of nutrients. Data requirements for claims based on the essentiality of nutrients differ compared to other claims, e.g. for the characterisation of the food/constituent, for the characterisation of the claimed effect, for the scientific substantiation of the claim and for establishing conditions of use. https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_a... |
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