Schering-Plough - Comment

Document ID: FDA-2007-D-0369-0022
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: December 04 2008, at 03:32 PM Eastern Standard Time
Date Posted: December 4 2008, at 12:00 AM Eastern Standard Time
Comment Start Date: May 30 2007, at 12:00 AM Eastern Standard Time
Comment Due Date: December 4 2008, at 11:59 PM Eastern Standard Time
Tracking Number: 807cd3f7
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This is comment on Notice

Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

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In response to the recently issued new draft product-specific BE guidance for posaconazole, Schering-Plough is providing comments and recommendations to assure that generic posaconazole products provide the appropriate exposure of posaconazole when administered under the approved indications and conditions of use to assure safe and efficacious use in patients.

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Schering-Plough - Comment

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Schering-Plough - Comment

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Related Comments

Total: 2

Abbott - Comment
Public Submission Posted: 12/04/2008 ID: FDA-2007-D-0369-0021

Comment Period Closed
Dec 04,2008 11:59 PM ET

Schering-Plough - Comment
Public Submission Posted: 12/04/2008 ID: FDA-2007-D-0369-0022

Comment Period Closed
Dec 04,2008 11:59 PM ET