Orphan Drug Regulations

Document ID: FDA-2011-N-0583-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Administrative Practices and Procedures, Drugs, Investigations, Medical Research, Reporting and Recordkeeping Requirements
Federal Register Number: 2011-27037
CFR Citation: 21 CFR Part 316
View Document:  View as format pdf View as format html

Details Information

Abstract: RIN 0910-AG72
Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: October 19 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 64868 - 64879
Page Count: 12
Comment Start Date: October 19 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: January 17 2012, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 12
Emma Rachelle Surber - Comment
Posted: 11/22/2011     ID: FDA-2011-N-0583-0002

Jan 17,2012 11:59 PM ET
Depomed, Inc. - Comment
Posted: 02/06/2012     ID: FDA-2011-N-0583-0003

Jan 17,2012 11:59 PM ET
Shire Human Genetic Therapies - Comment
Posted: 02/06/2012     ID: FDA-2011-N-0583-0004

Jan 17,2012 11:59 PM ET
Catholic Health Initiatives - Comment
Posted: 02/15/2012     ID: FDA-2011-N-0583-0005

Jan 17,2012 11:59 PM ET
GlaxoSmithKline GSK - Comment
Posted: 02/15/2012     ID: FDA-2011-N-0583-0006

Jan 17,2012 11:59 PM ET

Related Documents

   
Total: 1