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Wed, 07/18/2007 - 05:12

My First Blog

So, suffice it to say, I am approaching 50 years old and thus have never blogged before, but the idea was planted last year at an industry award dinner when I was seated at a table with the award winning blogger, who blogged about fashion, and was about my age. So, I figured (as I have with everything from regulatory submissions to parenting), if she can do it so can I!

Here goes . . . who am I?

PIM

Submitted by admin on Thu, 05/31/2007 - 12:59.

Is it mandatory to use PIM?

Submitting MAAs via the Centralised Procedure

Submitted by admin on Thu, 05/31/2007 - 12:58.

If I submit an MAA via the centralised procedure in eCTD do I still have to submit paper?

Converting an NDA into an MAA

Submitted by admin on Thu, 05/31/2007 - 13:01.

I have already submitted an NDA and I’m planning an MAA. What are the key differences from a formatting perspective?

DDMAC Submissions?

Submitted by admin on Fri, 03/16/2007 - 14:24.

Can I submit promotional material to DDMAC via eCTD?

Orhpan Drug Application

Submitted by admin on Fri, 03/16/2007 - 14:29.

Where in the eCTD do I put my orphan drug application?

eAF

Submitted by admin on Fri, 03/16/2007 - 18:46.

Am I required to submit the electronic application form with eCTD?

Submission Document Authoring

Submitted by admin on Wed, 02/07/2007 - 18:41.

Do most organizations have a style guide that is being used for submission documents?

Financial Disclosure Forms

Submitted by admin on Fri, 03/16/2007 - 14:28.

What studies do you need to submit financial disclosure for?

Stability Datasets

Submitted by admin on Fri, 03/16/2007 - 14:30.

How do I submit stability datasets?

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