Enforce the FDC Act to Prevent the Use of REMS to Block or Delay Generic Competition

 
Docket ID: FDA-2009-P-0266
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: Enforce the FDC Act to Prevent the Use of REMS to Block or Delay Generic Competition
Keyword(s): FDC Act, Dr. Reddy's Laboratories, Inc., REMS, Risk Evaluation, Mitigation Strategy, Generic Drugs, CDER
Type: Nonrulemaking
Center: CDER
Docket Item Code: P
 

Primary Documents

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Comment Period Closed
Other
Posted: 08/09/2013
ID: FDA-2009-P-0266-0006
Comment Period Closed
Other
Posted: 12/14/2009
ID: FDA-2009-P-0266-0005
Other
Posted: 06/15/2009
ID: FDA-2009-P-0266-0001
Comment Period Closed
Other
Posted: 06/15/2009
ID: FDA-2009-P-0266-0003

Supporting Documents

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Comments Not Accepted
Supporting & Related Material
Posted: 06/15/2009
ID: FDA-2009-P-0266-0002

Comments

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1
Comments Received*
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