Current Good Manufacturing Practice Requirements for Combination Products-CLOSED

Docket ID: FDA-2009-N-0435
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
September 23, 2009 (74 FR 48423) FR document published with an incorrect docket number. This FR document was published to correct the Docket ID (FDA-2008-D-0409) 78 FR 4307 7/22/2013, Rules and Regulations published which closed the docket
Docket Details open glossary dialog  
Related RINs: None
Short Title: Current Good Manufacturing Practice Requirements for Combination Products
Keyword(s): Current Good Manufacturing Practice , Requirements, Combination Products, oc200625, cGMP, codify, drugs, devices, biological products
Legacy ID: FDA-2004-D-0123 and FDA-2008-D-0409
Type: Nonrulemaking
Docket Status: CLOSED
Center: OC
Docket Item Code: N

Primary Documents

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Comment Period Closed
Feb 05, 2010 11:59 PM ET
Proposed Rule
Posted: 11/10/2009
ID: FDA-2009-N-0435-0004
Comment Period Closed
Dec 22, 2009 11:59 PM ET
Proposed Rule
Posted: 09/23/2009
ID: FDA-2009-N-0435-0001
Comment Period Closed
Posted: 01/22/2013
ID: FDA-2009-N-0435-0027
Comment Period Closed
Posted: 05/16/2011
ID: FDA-2009-N-0435-0026
Comments Not Accepted
Proposed Rule
Posted: 10/05/2009
ID: FDA-2009-N-0435-0002

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.