Biologics Price Competition and Innovation Act of 2009; Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 through 2017; Request for Comments

Docket ID: FDA-2011-N-0326
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Keyword(s): Biologics Price Competition , 2013-2017, cder201132
Type: Nonrulemaking
Center: CDER
Docket Item Code: N

Primary Documents

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Comment Period Closed
Jan 06, 2012 11:59 PM ET
Posted: 12/07/2011
ID: FDA-2011-N-0326-0024
Comment Period Closed
Jun 09, 2011 11:59 PM ET
Posted: 05/10/2011
ID: FDA-2011-N-0326-0001
Comment Period Closed
Posted: 01/11/2012
ID: FDA-2011-N-0326-0029

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.