International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances; Availability

Docket ID: FDA-2011-D-0436
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Keyword(s): cder, cder201188, International Conference, Q11
Type: Nonrulemaking
Center: CDER
Docket Item Code: D

Primary Documents

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Comment Period Closed
Sep 01, 2011 11:59 PM ET
Posted: 06/29/2011
ID: FDA-2011-D-0436-0001
Comment Period Closed
Posted: 11/20/2012
ID: FDA-2011-D-0436-0026

Supporting Documents

No documents available.


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Comments Received*
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.