Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments

 
Docket ID: FDA-2011-D-0618
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: Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments
Keyword(s): cder, cder2011121, biosimilar products, public hearing
Type: Nonrulemaking
Docket Status: OPEN
Center: CDER
Docket Item Code: D
 

Primary Documents

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Comment Period Closed
May 25, 2012 11:59 PM ET
Notice
Posted: 04/02/2012
ID: FDA-2011-D-0618-0002
Comment Period Closed
May 01, 2012 11:59 PM ET
Notice
Posted: 03/02/2012
ID: FDA-2011-D-0618-0001
Comment Period Closed
Other
Posted: 05/30/2012
ID: FDA-2011-D-0618-0066
Comment Period Closed
Other
Posted: 05/10/2012
ID: FDA-2011-D-0618-0043
Comment Period Closed
Other
Posted: 05/09/2012
ID: FDA-2011-D-0618-0010

Supporting Documents

 
No documents available.

Comments

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33
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.