eLaws | eCases | United States Code | Federal Courts |
Home » Rulemaking » Current Good Manufacturing Practice Requirements for Combination Products

Current Good Manufacturing Practice Requirements for Combination Products

Document ID: FDA-2009-N-0435-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Biological Products, Cellular and Tissue-Based Products, Combination Products, Devices, Drugs, Human Cell, Regulation of Combination Products, Tissue
Federal Register Number: E9-22850
CFR Citation: 21 CFR 4
View Document:  View as format pdf View as format html

Details Information

Abstract: This notice was published under FDA-2008-D-0409. The correct number is FDA-2009-N-0435. A Notice of Correction will follow.
Document Subtype: NPR-Notice of Proposed Rule-Making
Received Date: September 22 2009, at 11:44 AM Eastern Daylight Time
Start-End Page: 48423 - 48431
Page Count: 9
Comment Start Date: September 23 2009, at 12:00 AM Eastern Standard Time
Comment Due Date: December 22 2009, at 11:59 PM Eastern Standard Time

Comments

   
Total: 5
Genentech - Comment
Posted: 11/24/2009     ID: FDA-2009-N-0435-0005

Dec 22,2009 11:59 PM ET
Pharmaceutical Research and Manufacturers of America (PhRMA) - Comment
Posted: 01/05/2010     ID: FDA-2009-N-0435-0007

Dec 22,2009 11:59 PM ET
TMI Regulatory Compliance Consulting - Comment
Posted: 02/03/2010     ID: FDA-2009-N-0435-0014

Dec 22,2009 11:59 PM ET
Anonymous - Comment
Posted: 10/14/2009     ID: FDA-2009-N-0435-0003

Dec 22,2009 11:59 PM ET
BIOTRONIK, Inc. - Comment
Posted: 12/23/2009     ID: FDA-2009-N-0435-0006

Dec 22,2009 11:59 PM ET

Related Documents

   
Total: 3