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From the 21 CFR Part 11 regulation: Sec. 11.1 Scope. "(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations . This part also applies to electronic records submitted to the agency under requirements of the Federal ...

I'd just like to mention that having the eCTD templates is not enough. You will need the software to place the resulting pdfs in the eCTD backbone and create the XML files for submission. There are several companies that offer such software, but it is pricey. As a result, small firms often go to companies that have eCTD software for final publishing ...

​​Hi RAPS members, Last friday, President Trump signed an executive order which targets essential drugs and devices.  Does any one know scope of essential drugs and devices? which drugs and devices are falls in the scope of essential drugs and devices? Related news is below. https://www.raps.org/news-and-articles/news-articles/2020/8/trumps-buy-american-order-tasks-fda-on-essential-d?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%207%20August%202020 ...

Hi, Single DMF with two different specifications is not possible. ------------------------------ [Deepa] [Dasgupta, RAC] [Director] Director Hyderabad [India] ------------------------------

Please contact Katherine L. Ulman, kathyulman@yahoo.com.  She has extensive experience with DMFs, is an expert on DMFs, and a faculty member with us at: esubmissionsuniversity.com  I am retired from the eCTD for-profit community and have no commercial or financial interest in making this recommendation. ------------------------------ S. Albert Edwards ...