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Re: Biobillionair post# 8040

Thursday, 06/06/2013 2:34:03 PM

Thursday, June 06, 2013 2:34:03 PM

Post# of 426487
Could the Lovaza Citizen petition filed by Crowell-Moring be holding up NCE?

IMO, yes.
My FDA email:
-------------

The decision on this petition should be done sometime in August.


The time frame to respond to this petition is 180 days. Therefore, it should be sometime in August.


Gloria Ortega
Administrative Proceedings Officer
FDA/Office of the Executive Secretariat (OES)
5630 Fishers Lane
Rockville, MD 20852


-----Original Message-----
From: Williams
Sent: Wednesday, June 05, 2013 4:03 PM
To: Ortega, Gloria M
Subject: Lovaza Citizen Petition FDA-2013-P-0148/CP1

Ms. Ortega,

When can we expect a response from CDER regarding the 2-6-2013 Citizen Petition filed by Crowell-Moring?

Thank you,


Williams
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