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RE: FDA and translations (was How do you ensure the quality of translations)
Subject:RE: FDA and translations (was How do you ensure the quality of translations) From:"Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com> To:<techwr-l -at- lists -dot- techwr-l -dot- com> Date:Mon, 27 Jul 2009 12:01:37 -0400
Sorry -- MDD, not FDA.
IH8 TLAs -- U2?
> -----Original Message-----
> From: Deborah Hemstreet
> Sent: Monday, July 27, 2009 11:30 AM
> To: Dan Goldstein
> Cc: techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: FDA and translations (was How do you ensure the
> quality of translations)
> Hi Dan,
> ... By the way, I'd be interested, you mentioned FDA. To the best
> of my knowledge, there are no requirements per se regarding
> translation (from the FDA). Has that changed? If so, could
> you point me to the link on their site to read up about that?
> I know that the EU and individual countries have
> requirements, but was not aware the FDA had started looking
> at translations of stuff... or is it only pharmaceuticals? We
> were dealing with medical devices.
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