Back to the Top
The following message was posted to: PharmPK
Dear all,
i have one query that what isthe difference between
505b(2) and suitability petition, since definition wise both are seems
to be
equivalent for filling.
(Both are sameness as different dosage form,dose and label claim).
In case of suitability petition is there require any additionalstudies
like
clinical studies.
Is there any literature for this difference,plz provide me soon..
Waiting in anticipation,
With regards,
alkesh
Back to the Top
Dear, there seems to be little overlapping between the 2. However if you
may weigh the possibility of classifying your case as suitability
petition, then the charges for submission would be less but you will
lose on benefits of any kind of exclusivity. In case you justify your
case to be 505 b(2) submission, then you may end up doing clinical
studies for the dosage form. Yes you will get exclusivity benefits but
then cost of submission is going to be very high.
Any comments/ inputs!!
Regards
Manoj K. Paruthi, Ph.D.
Sr. Manager, Head, R&D
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Difference between 505b(2) and suitability petition" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)