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Sterility Test Requirements for Biological Products

Document ID: FDA-2011-N-0080-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Biologics, Labeling, Reporting and Recordkeeping Requirements
Federal Register Number: 2011-15346
CFR Citation: 21 CFR Parts 600, 610, and 680
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Details Information

Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: June 21 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 36019 - 36027
Page Count: 9
Comment Start Date: June 21 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: September 19 2011, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 17
GlaxoSmithKline - Comment
Posted: 09/29/2011     ID: FDA-2011-N-0080-0003

Sep 19,2011 11:59 PM ET
Novo Nordisk Inc. - Comment
Posted: 09/29/2011     ID: FDA-2011-N-0080-0004

Sep 19,2011 11:59 PM ET
Celgene Corporation - Comment
Posted: 09/29/2011     ID: FDA-2011-N-0080-0005

Sep 19,2011 11:59 PM ET
ISPE - Comment
Posted: 09/29/2011     ID: FDA-2011-N-0080-0006

Sep 19,2011 11:59 PM ET
Pfizer Inc. - Comment
Posted: 09/29/2011     ID: FDA-2011-N-0080-0008

Sep 19,2011 11:59 PM ET

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