|Spanish to English translations [PRO]|
Medical - Medical (general) / Research report for new drug
|Spanish term or phrase: El adjunto de seguridad|
|El adjunto de seguridad incluye los listados de efectos adversos graves clasificados como relacionados con el fármaco o no, por paciente, en los estudios sobre MDD y VMS.|
|enclosed safety summary|
When clinical testing has been completed and analyzed, final manufacturing processes and procedures are in place, and the company has ready other required information, it must submit a New Drug Application (NDA) to the FDA. No action can be taken to market any therapeutic drug product in the U.S. until the FDA has approved an NDA.
The data in the NDA must establish that the drug is safe for use under the proposed labeling conditions and is effective for its proposed use(s). Substantial evidence is defined by statute and FDA regulation to mean evidence consisting of adequate and well-controlled investigations, including clinical investigations by experts qualified by scientific training and experience, to evaluate the effectiveness of the drug involved.
The NDA must contain data-obtained outlines from the clinical trials of the drug, as well as a description and analysis of the drug’s pharmacokinetics. It must also include a description and analysis of any other data relevant to the safety and effectiveness of the drug product obtained from any source, foreign or domestic.
The NDA also includes an integrated summary of all available information about the safety of the drug product, including potential adverse effects and clinically significant potential adverse reactions with other related drugs.
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Local time: 22:12
|Thanks Liz :-)|
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Safety exhibit / schedule / section
creo que cualquiera de ellas serviría.
Local time: 16:12
Works in field
Native speaker of: Spanish
PRO pts in category: 35
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Even if this is an attached document, it still has to be called a "safety something".
Given the content described, "Safety report" seems a logical translation, as that, in effect is what happenes, these adverse effects are 'reported' to a health authority.
Online Ethics Center: Ethical and Policy Issues in Research ...
(1) Unanticipated adverse device effects. An investigator shall submit to the ... Followup information to a safety report shall be submitted as soon as the ...onlineethics.org/reseth/nbac/happendixh.html - 21k - Cached - Similar pages
A systematic review of the safety profile of levetiracetam: a new ...
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*Volunteers/Researchers*, G-therapy : Safety Report ... of few months to couple of years and has proved to be very safe, with almost no adverse effects. ...www.g-therapy.org/safety.htm - 16k - Cached - Similar pages
FEHB Patient Safety Information for the Bluecare Network of MI
Pharmacy Quality/Safety Report: Prevention of Adverse Effects in Elderly Patients. During 2003, Blue Care Network moved into its third year of quarterly ...www.opm.gov/insure/04/safety/g7.asp - 19k - Cached - Similar pages
Drug report barred by FDA / Scientist links antidepressants to ...
... Arava, which had generated numerous reports of adverse effects, ... who had prepared a 37-page safety report, were present at the hearing but were not ...www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/02/01/MNG... - 31k - Cached - Similar pages
Local time: 23:12
Specializes in field
Native speaker of: English
PRO pts in category: 100
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