Electronic Source Documentation in Clinical Investigations

Docket ID: FDA-2010-D-0643
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
Short Title: Industry on Electronic Source Documentation in Clinical Investigations; Availability
Keyword(s): oc2009328, Clinical Investigations, Electronic Source , Documentation
Type: Nonrulemaking
Docket Status: OPEN
Center: OC
Docket Item Code: D

Primary Documents

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Comment Period Closed
Mar 26, 2013 11:59 PM ET
Posted: 11/20/2012
ID: FDA-2010-D-0643-0045
Comment Period Closed
Apr 07, 2011 11:59 PM ET
Posted: 01/07/2011
ID: FDA-2010-D-0643-0001
Comment Period Closed
Apr 07, 2011 11:59 PM ET
Posted: 01/07/2011
ID: FDA-2010-D-0643-0002
Comment Period Closed
Posted: 09/18/2013
ID: FDA-2010-D-0643-0091

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.