Charles,
Based on your description (for example, non-GMP, no ANDA submission), you don't seem to fall under five categories set out under GDUFA 2012 and Title III of FDASIA 2012. Please read the statutes and FDA guidance below.
http://www.fdaguidance.net/gdufa-self-identification-of-generic-drug-facilities-sites-and-organizations/ You can always call FDA to inquire further...
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http://www.regulatorydoctor.com Riner VA
United States
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Original Message:
Sent: 04-21-2014 19:02
From: Charles Van Beveren
Subject: Timing of Self-identification and GDUFA Fees
We are preparing to manufacture a generic for a client. To date we have manufactured generic non-GMP and clinical material for bio-equivalency/bio-availability studies. No commercial manufacturing has occurred and ANDA(s) have not been submitted.
When will we be responsible to self-identify as a generic manufacturer and pay the associated GDUFA fees? Are we responsible for filing during the current reporting period, ending April 30, 2014?
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Charles P Van Beveren, PhD, RAC
San Diego CA
United States
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