Top Regulatory Tips: Tips 9 & 10

Friday, March 13, 2009

Part 5 of Top Regulatory Tips

View part: [ 1 | 2 | 3 | 4 | 5 ]

Previously:
« Tips 7 & 8


It's Friday the 13th but that doesn't scare me! Let's finish the week with Tips 9 and 10.

Tip 9: Make the manufacturing process is developed before clinical trials are initiated

Before starting important clincial trials, make sure the manufacturing process being used is repetable and scalable. Identify critical process steps and find out if large-scale maufacture is possible and cost effective. Make sure you have at least some stability data. FDA will want to see data from more than one lot. If you start your clinical on your first lot and things end up changing for the second and third, the validity of the study could be challenged. Take a second look and make sure your really ready to go before collecting that first clinical trial data point.

Tip 10: Focus

Regulatory approvals require narrow and constant focus. The most successful projects I've worked on have a dedicated product team who's only job it is to get a product through FDA and onto the marketplace. Get a good team of experienced diagnostic types and keep them them focused!

Enjoy your weekend! Hopefully you've got a few extra ideas to incorporate into next week's work.

Tags: 510(k), Best Practices, FDA, FDA 101, QSR, Reagents

Part 5 of Top Regulatory Tips

View part: [ 1 | 2 | 3 | 4 | 5 ]

Previously:
« Tips 7 & 8


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