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

-----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