Charles,
Not sure I understood your question. Is the new generic drug you are preparing to manufacture an FDA approved drug for commercial distribution? If you answer is yes, then you will need to identify as a generic manufacturer before you initiate manufacturing. Your client will have to add you to their NDA and you will also have to obtain FDA approval to manufacture drug products for commercial distribution.
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Elvira Marquez
San Diego CA
United States
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Original Message:
Sent: 04-22-2014 11:01
From: Chang Lim
Subject: Timing of Self-identification and GDUFA Fees
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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