Bioequivalence and Bioavailability Forum

Hi Mei San,

❝ It seems that USFDA did require both fasting & fed study for most of the molecules.

Correct.

❝ May I know on what basis they provide such recommendation?

We can’t read the FDA’s minds… Either the FDA wants to play it safe or has information about a food effect which is not stated in the RLD’s label. For an example see this post.

❝ Can I skip fed study and perform fasting study only?

Without proper justification, you should not deviate from a guidance. See ANDA Submissions – Refuse-to-Receive Standards (Section VI.B.):

FDA will refuse-to-receive an ANDA if the ANDA contains a non-recommended in vivo study without adequate justification. Adequate justification should include justification for an approach that deviates from FDA posted guidance, including data (Module 2.7 and Module 5) and appropriate references. We encourage applicants to consult the BE recommendations Web page for product-specific study information or to contact OGD’s Division of Bioequivalence via a BE Guidance Request for further guidance, if needed.

(my emphasis)