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3674 Fda Form

3674 Fda Form

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Instructions and help about 3674 Fda Form

all right thank you so much all right so as she said I'm John Oro I'm talking today about improving the sterility Assurance application to the FDA so the way I have this set up just give you a little background I've asked managers reviewers a bunch of people in microbiology for the last 10 plus years what they see as the most common problems in applications then we all discussed and we thought okay these are these are the big things I'm going to talk about them we're going to keep trying to hammer this home so we can improve the submissions so the first thing it might seem obvious but I think this is worth it make it easy to read so quick story I like to ramble when I left grad school I ended up in a patent law firm and one of the senior attorneys said to me when you're trying to make a point say what you want to say in the beginning say it again in the middle and then say it again at the end now that doesn't exactly apply here bu

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