question about clinical trial

Pharmagal
Thu, 12 Jul 2007 19:32:58 +0000

Hi Aihara,

There are strict FDA regulated guidelines for approvals of products. The list of do’s and don’t is way too lengthy for me to detail out here also my specialty deals with NCEs (new chemical entities for INDs and NDAs). Therefore, I couldn’t comment on device approvals.

I would advice you to read these guidelines. Pretty much everything you need can be found by googling the ICH guidelines and FDA guidelines.

Here’s a link to FDA’s page for devices.

http://www.fda.gov/cber/gdlns/bioplant.htm

Also peruse the ICH guidelines. CFR 21 applies for everything clinical.

Enjoy perusing and good luck!