Hi everyone,
As formulators, we might be facing some challenges regarding approval process of "novel" excipients used in drug products with FDA . I am not sure if FDA has become too "defensive" in approving new excipients, but they are lately asking for lot more of toxicological data from clinical perspective. FDA has initiated their new PRIME program (link below) but it has not been very useful based on the limited number of excipients approved via this route. FDA's Inactive Ingredient Database, though helpful in some instances, but doesn't directly support innovation and use of novel materials.
I'd like to reach out to you to understand if anyone has any success using "abbreviated routes" in getting approval. I am wondering if the following had been used successfully in getting approvals. They are:
- SAR based toxicological studies and FDA's preferred methods/vendors for doing those (I know Gad consulting is one)
- Innovative in vitro, ex vivo toxicological models such as cell or tissue culture and FDA's preferred methods/vendors for doing those
- Any other toxicological evaluation accepted by FDA without the use of clinical programs which are getting costlier for the sponsors of NDA
I'd really appreciate any comments on this topic.
Thanks and best regards,
Deb.
Novel Excipient Review Pilot Program
| U.S. Food and Drug Administration |
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Debanjan (Deb) Das
Sr.Associate Director
Global R&D
Bayer Healthcare
NJ, USA
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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