2004N-0087 - Request for Comment on Generic Drug Issues
  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  

  



  

  
Submitter : 
  

  
Mrs. Kathleen Jaeger
  

  
Date & Time: 
  

  
05/03/2004 06:05:17
  



  

  
Organization : 
  

  
Generic Pharmaceutical Association
  



  

  
Drug Association
  


  

  
Category : 
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 

-----Original Message-----

From: Kathleen D. Jaeger 

Sent: Friday, April 30, 2004 4:53 PM

To: 'Edutra@oc.fda.gov'

Subject: Request for Extension of Comment Period (Docket 2004N-0087)

Importance: High



To: Dockets Management Branch

    Food and Drug Administration

    Department of Health & Human Services

    5630 Fishers Lane   Room 1061

    Rockville, Maryland 20857



Re: Request for Extension of Comment Period 

    Docket No. 2004N-0087: Generic Drug Issues; Request for Comments



The Generic Pharmaceutical Association (GPhA) submits this petition pursuant to FDA regulation 10.35 requesting that the Commissioner of Food and Drugs extend the comment period by two days on whether additional regulatory actions should be taken concerning the approval of abbreviated new drug applications (ANDAs). See 69 Fed. Reg. 9982 (Mar. 3, 2004) (Docket No. 2004N-0087). GPhA requests the two day extension so that we may complete our association comment process.   



Submitted By: 

 

Kathleen Jaeger

President & CEO

Generic Pharmaceutical Association

2300 Clarendon Blvd; Suite 400

Arlington, VA 22201

Direct: 703.647.2490

Fax:    703.647.2481