Correspondence with the FDA
Trent's correspondence and replies from the FDA
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Date: 11/02/2010
Size: 15 items
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E-mail from Sacramento FDA Office - 29-Apr-2009
E-mail from Sacramento FDA Office - 29-Apr-2009
Date: 12/06/2010
Views: 9645
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E-mail from Sacramento FDA Office - 29-Apr-2009
Date: 12/06/2010
Views: 3509
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FDA Motion to Deny Hearing 07-Feb-2010 (PDF)
FDA Motion to Deny Hearing and Issue Administrative Judgement
Date: 02/09/2011
Views: 3408
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Follow-Up Letter to FDA CBER (Center for Biologics Evaluation and Research) 28-Nov-2010 Page 1 of 1
Follow-Up Letter to FDA CBER (Center for Biologics Evaluation and Research) 28-Nov-2010 Page 1 of 1
Date: 12/05/2010
Views: 8382
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Follow-Up Letter to FDA CBER (Center for Biologics Evaluation and Research) 28-Nov-2010 Page 1 of 1 (PDF)
Date: 12/05/2010
Views: 3373
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Letter to FDA Commissioner Margaret Hamburg 28-Nov-2010 (2 Page PDF)
Date: 12/05/2010
Views: 3293
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Letter to FDA Commissioner Margaret Hamburg 28-Nov-2010 Page 1 of 2
Letter to FDA Commissioner Margaret Hamburg 28-Nov-2010 Page 1 of 2
Date: 12/05/2010
Views: 8266
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Letter to FDA Commissioner Margaret Hamburg 28-Nov-2010 Page 2 of 2
Letter to FDA Commissioner Margaret Hamburg 28-Nov-2010 Page 2 of 2
Date: 12/05/2010
Views: 7370
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Reply to FDA Inspection and Cease Order - 01-Nov-2010 - Page 1 of 2
Response to FDA Inspection - Page 1 of 2 (Signed)
Date: 11/02/2010
Views: 7857
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Reply to FDA Inspection and Cease Order - 01-Nov-2010 - Page 2 of 2
Response to FDA Inspection - 01-Nov-2010 - Page 2 of 2
Date: 11/02/2010
Views: 7361
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Request for Extension FDA Reply - 7 Oct 2010
FDA Request for Extension Reply - 7 Oct 2010
Date: 11/02/2010
Views: 8250
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Request for Extension FDA Reply - 7 Oct 2010
Date: 12/05/2010
Views: 3368
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Request for Extension to Reply to Form 483 Observations - 01-Oct-2010
Date: 12/05/2010
Views: 3372
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Request for Extension to Reply to Form 483 Observations - 1 Oct 2010
Request for Extension to Reply to Form 483 Observations - 1 Oct 2010
Date: 11/02/2010
Views: 8284
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Response to Cease Manufacturing and Form 483 in PDF Format
Date: 11/02/2010
Views: 3622
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