Request that FDA Confirm That it Will not Accept for Filing,File, Approve or Discuss With any Prospective Applicant a Product That Cites, as its Reference Product, BLA 125057 for Humira® (adalimumab) or Any other Product for which BLA was Submitted to FDA Prior March 23, 2010

 
Docket ID: FDA-2012-P-0317
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Lead Office for this Petition is CDER
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: FDA Will not Accept for Filing Approve or Discuss With any Prospective Applicant a Product That Cites as its Reference Product, BLA 125057 for Humira® (adalimumab) or Any other Product
Keyword(s): cber, adalimumab, Humira, BLA 125057 , IND, CDER, open
Type: Nonrulemaking
Docket Status: OPEN
Center: CDER
Docket Item Code: P
 

Primary Documents

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Comment Period Closed
Other
Posted: 10/22/2012
ID: FDA-2012-P-0317-0005
Comment Period Closed
Other
Posted: 05/08/2012
ID: FDA-2012-P-0317-0002
Other
Posted: 05/08/2012
ID: FDA-2012-P-0317-0001

Supporting Documents

 
No documents available.

Comments

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5
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.