Correspondence with the FDA
Trent's correspondence and replies from the FDA
|
Date: 11/02/2010
Size: 15 items
|
|
|
E-mail from Sacramento FDA Office - 29-Apr-2009
E-mail from Sacramento FDA Office - 29-Apr-2009
Date: 12/05/2010
Views: 6713
|
|
E-mail from Sacramento FDA Office - 29-Apr-2009
Date: 12/05/2010
Views: 2415
|
|
FDA Motion to Deny Hearing 07-Feb-2010 (PDF)
FDA Motion to Deny Hearing and Issue Administrative Judgement
Date: 02/08/2011
Views: 2322
|
|
|
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: 12/04/2010
Views: 5673
|
|
Follow-Up Letter to FDA CBER (Center for Biologics Evaluation and Research) 28-Nov-2010 Page 1 of 1 (PDF)
Date: 12/04/2010
Views: 2256
|
|
Letter to FDA Commissioner Margaret Hamburg 28-Nov-2010 (2 Page PDF)
Date: 12/04/2010
Views: 2219
|
|
|
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: 12/04/2010
Views: 5636
|
|
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: 12/04/2010
Views: 5001
|
|
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: 5446
|
|
|
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: 5028
|
|
Request for Extension FDA Reply - 7 Oct 2010
FDA Request for Extension Reply - 7 Oct 2010
Date: 11/02/2010
Views: 5756
|
|
Request for Extension FDA Reply - 7 Oct 2010
Date: 12/04/2010
Views: 2258
|
|
|
Request for Extension to Reply to Form 483 Observations - 01-Oct-2010
Date: 12/04/2010
Views: 2299
|
|
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: 5819
|
|
Response to Cease Manufacturing and Form 483 in PDF Format
Date: 11/02/2010
Views: 2537
|
