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Mei San
Junior

Malaysia,
2016-10-24 04:29

Posting: # 16750
Views: 2,570
 

 Fasting & Fed Study based on USFDA Guidelines [Regulatives / Guidelines]

Hi everyone,

It seems that USFDA did require both fasting & fed study for most of the molecules. May I know on what basis they provide such recommendation?

Can I skip fed study and perform fasting study only?

Kindly advise.

Many thanks.
Helmut
Hero
Homepage
Vienna, Austria,
2016-10-24 10:06

@ Mei San
Posting: # 16751
Views: 2,052
 

 ANDA Submissions – Refuse-to-Receive Standards

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)

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Science Quotes
jag009
Hero

NJ,
2016-12-18 07:37

@ Mei San
Posting: # 16853
Views: 734
 

 Fasting & Fed Study based on USFDA Guidelines

They play safe. If they don't ask for fed (unless there is safety issue) then what happens if your generic formulation has a food effect whereas the reference doesn't?

Another thing I hate about PM (product monograph) for some drugs is the lack of a no food effect sentence when the drug has no food effect. Some PM has it and some PM doesn't.

John
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