Comments for the Eagle's Nest Blog http://aecanal.com Comments relating to practical implementation of the eCTD Wed, 15 Feb 2012 17:41:18 +0000 hourly 1 http://wordpress.org/?v=3.3.2 Comment on FDA Fillable Forms by Monte http://feedproxy.google.com/~r/EaglesNestCommentsRSS/~3/1ymaadCgPD8/ Monte Wed, 15 Feb 2012 17:41:18 +0000 http://aecanal.com/wp-test/?p=31#comment-270 I would recommend just including the number in the form field. If you want a more authoritative answer you should send your question to esub@fda.hhs.gov, which is the address for the electronic submissions group at FDA. They are very responsive and very helpful. Monte I would recommend just including the number in the form field. If you want a more authoritative answer you should send your question to esub@fda.hhs.gov, which is the address for the electronic submissions group at FDA. They are very responsive and very helpful.

Monte

]]> http://aecanal.com/2009/11/fda-fillable-forms/comment-page-1/#comment-270 Comment on FDA Fillable Forms by Jinsoo http://feedproxy.google.com/~r/EaglesNestCommentsRSS/~3/MlCy7g-eUWU/ Jinsoo Fri, 10 Feb 2012 18:45:38 +0000 http://aecanal.com/wp-test/?p=31#comment-269 what if we put letters such as "NDA" or "ANDA" in application number field on the fillable 356h, will ASR reject the submission since it doesn't match with the application "number" on the xml? what if we put letters such as “NDA” or “ANDA” in application number field on the fillable 356h, will ASR reject the submission since it doesn’t match with the application “number” on the xml?

]]> http://aecanal.com/2009/11/fda-fillable-forms/comment-page-1/#comment-269 Comment on Background by 6 weeks … and counting - Thad Nodine http://feedproxy.google.com/~r/EaglesNestCommentsRSS/~3/JpWCb_hh7x4/ 6 weeks … and counting - Thad Nodine Sat, 13 Aug 2011 00:27:23 +0000 http://aecanal.com/wp-test/?page_id=18#comment-255 [...] - I’m figuring out WordPress (with an excellent web developer, Toni Rouhana, and web gurus Monte Levinson and Lee Glickenhaus) - I’m learning how to publish and publicize a Facebook page (thanks Libby [...] [...] – I’m figuring out WordPress (with an excellent web developer, Toni Rouhana, and web gurus Monte Levinson and Lee Glickenhaus) – I’m learning how to publish and publicize a Facebook page (thanks Libby [...]

]]> http://aecanal.com/background/comment-page-1/#comment-255 Comment on The Importance of eCTD Viewers by Žarko Gaji? http://feedproxy.google.com/~r/EaglesNestCommentsRSS/~3/ZxqwPLILFkE/ Žarko Gaji? Fri, 08 Jul 2011 09:15:25 +0000 http://aecanal.com/?p=241#comment-252 Thank you for the article. I can say it served as a base point for us to build our eCTD Viewer. -Žarko Gaji? (eCTD Office IT Project Manager) Thank you for the article. I can say it served as a base point for us to build our eCTD Viewer.

-Žarko Gaji? (eCTD Office IT Project Manager)

]]> http://aecanal.com/2010/01/the-importance-of-ectd-viewers/comment-page-1/#comment-252 Comment on FDA Fillable Forms by Monte http://feedproxy.google.com/~r/EaglesNestCommentsRSS/~3/12BbiZ3AB4M/ Monte Mon, 18 Oct 2010 17:27:12 +0000 http://aecanal.com/wp-test/?p=31#comment-180 Thanks for your comment, Sharon. I was unaware of the issue, and couldn't find any mention of it online. To test it out, I downloaded the 2253 form on a Windows 7 machine with Acrobat 9 and had no problems. When I downloaded the form on a Windows XP machine with Acrobat 7 I got a number of script errors. I was able to fill in the form fields and save the document using Acrobat 7, but the script errors didn't give me a lot of confidence that it was working correctly--even though it appeared to be OK. The form is in PDF 1.6 format, which should work with Acrobat 7, but clearly there is a problem. I recommend that you contact the agency to inform them of the problem and ask them to update the form with one that works correctly in Acrobat 7. You can contact the electronic submissions support team at esub@fda.hhs.gov. It probably wouldn't hurt to copy DDMAC and/or APLB to let them know as well. Monte Thanks for your comment, Sharon. I was unaware of the issue, and couldn’t find any mention of it online. To test it out, I downloaded the 2253 form on a Windows 7 machine with Acrobat 9 and had no problems. When I downloaded the form on a Windows XP machine with Acrobat 7 I got a number of script errors. I was able to fill in the form fields and save the document using Acrobat 7, but the script errors didn’t give me a lot of confidence that it was working correctly–even though it appeared to be OK. The form is in PDF 1.6 format, which should work with Acrobat 7, but clearly there is a problem.

I recommend that you contact the agency to inform them of the problem and ask them to update the form with one that works correctly in Acrobat 7. You can contact the electronic submissions support team at esub@fda.hhs.gov. It probably wouldn’t hurt to copy DDMAC and/or APLB to let them know as well.

Monte

]]> http://aecanal.com/2009/11/fda-fillable-forms/comment-page-1/#comment-180 Comment on FDA Fillable Forms by Sharon http://feedproxy.google.com/~r/EaglesNestCommentsRSS/~3/yGq_EXZZdyw/ Sharon Wed, 13 Oct 2010 23:10:30 +0000 http://aecanal.com/wp-test/?p=31#comment-179 Has anyone seen script errors with fillable form 2253. I can open this form (once filled in) using Acrobat 9 Pro, but other people using Acrobat 7 cannot. The scripting errors, I believe are java related, and the form properties say it is compatible with Acrobat 7. Do you know of any workarounds or debugging, or is this an FDA known issue. Thanks! Sharon P.S. This is an outstanding blog - great info. Has anyone seen script errors with fillable form 2253. I can open this form (once filled in) using Acrobat 9 Pro, but other people using Acrobat 7 cannot. The scripting errors, I believe are java related, and the form properties say it is compatible with Acrobat 7. Do you know of any workarounds or debugging, or is this an FDA known issue.

Thanks!
Sharon

P.S. This is an outstanding blog – great info.

]]> http://aecanal.com/2009/11/fda-fillable-forms/comment-page-1/#comment-179 Comment on Strategic Partnerships: A Regulatory Operations Perspective by Monte http://feedproxy.google.com/~r/EaglesNestCommentsRSS/~3/juZMvGxX63c/ Monte Thu, 27 May 2010 01:21:23 +0000 http://aecanal.com/?p=337#comment-144 Jon, Thanks for your comments. VDRs are not that expensive, and you can pay for most of them month to month. It doesn't take long to put one up, so you can use them as the need arises. Monte Jon,

Thanks for your comments. VDRs are not that expensive, and you can pay for most of them month to month. It doesn’t take long to put one up, so you can use them as the need arises.

Monte

]]> http://aecanal.com/2010/05/strategic-partner-interaction/comment-page-1/#comment-144 Comment on Strategic Partnerships: A Regulatory Operations Perspective by Jonathan http://feedproxy.google.com/~r/EaglesNestCommentsRSS/~3/CfoZQO3PCDo/ Jonathan Wed, 26 May 2010 19:44:36 +0000 http://aecanal.com/?p=337#comment-143 Awesome post as usual. Wouldn't expect anything less! Are VDRs very expensive? Small company + expensive + not very much due diligence = hard sell to get a P.O. Inexpensive, I can definitely see the reasoning from a cost efficiency standpoint. For big companies, its basically a must have I'd imagine. Awesome post as usual. Wouldn’t expect anything less!

Are VDRs very expensive? Small company + expensive + not very much due diligence = hard sell to get a P.O. Inexpensive, I can definitely see the reasoning from a cost efficiency standpoint.

For big companies, its basically a must have I’d imagine.

]]> http://aecanal.com/2010/05/strategic-partner-interaction/comment-page-1/#comment-143 Comment on Strategic Partnerships: A Regulatory Operations Perspective by Tweets that mention Strategic Partnerships: A Regulatory Operations Perspective | Aerie Canal Consulting -- Topsy.com http://feedproxy.google.com/~r/EaglesNestCommentsRSS/~3/BjKmYWpjd2Y/ Tweets that mention Strategic Partnerships: A Regulatory Operations Perspective | Aerie Canal Consulting -- Topsy.com Thu, 13 May 2010 13:01:16 +0000 http://aecanal.com/?p=337#comment-127 [...] This post was mentioned on Twitter by Kathie Clark, Monte Levinson. Monte Levinson said: New post: Strategic Partnerships: A Regulatory Operations Perspective http://bit.ly/aEmDbA [...] [...] This post was mentioned on Twitter by Kathie Clark, Monte Levinson. Monte Levinson said: New post: Strategic Partnerships: A Regulatory Operations Perspective http://bit.ly/aEmDbA [...]

]]> http://aecanal.com/2010/05/strategic-partner-interaction/comment-page-1/#comment-127 Comment on FDA Fillable Forms by Monte http://feedproxy.google.com/~r/EaglesNestCommentsRSS/~3/muzrXwzAo_8/ Monte Wed, 12 May 2010 18:20:13 +0000 http://aecanal.com/wp-test/?p=31#comment-125 Johnny, The FDA performs 3 levels of validation checks. The first is the Automated Submission Receipt (ASR) which is where the fillable form is examined and the application number verified. I have only seen this system discussed in agency presentations at eCTD conferences. I don't have a reference that explains it fully, but check out the links, below. Monte http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM166274.pdf http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM166277.pdf http://theectdsummit.com/summit/?p=262 Johnny,

The FDA performs 3 levels of validation checks. The first is the Automated Submission Receipt (ASR) which is where the fillable form is examined and the application number verified. I have only seen this system discussed in agency presentations at eCTD conferences. I don’t have a reference that explains it fully, but check out the links, below.

Monte

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM166274.pdf

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM166277.pdf

http://theectdsummit.com/summit/?p=262

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