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Meeting for Public Comment
Pilot Program to Evaluate Proposed Name Submissions
The public meeting was held on June 5 and 6, 2008, from 8:30 a.m. to 5:00 p.m.
Any written or electronic comments regarding the concept paper and pilot program were submitted by by July 6, 2008.
If you would like to make an oral presentation during the meeting, you must register and provide an abstract of your presentation by close of business on May 6, 2008. You must provide your name, title, business affiliation (if applicable), address, telephone and fax numbers, and e-mail address to Lana Pauls. You should identify the topic or section of the draft concept paper you wish to address in your presentation, whether you wish to address comments on day one or day two, and the approximate time requested for your presentation.
If you need special accommodations because of disability, please contact Lana Pauls at least seven days before the meeting.
Address: The public meeting will be held at the Crowne Plaza Hotel, 877 Georgia Ave., Silver Spring, MD 20910 (Metro: Silver Spring Station on the Red Line).
Summary: The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public technical meeting in preparation for a pilot program to enable pharmaceutical firms to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review. The purpose of the public technical meeting is to discuss a concept paper that describes the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA plans to formally issue the concept paper by the end of fiscal year (FY) 2008 and expects to begin enrollment in the pilot program in FY 2009.
Comment Submissions: Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to: http://www.regulations.gov.
For Further Information Contact:
Lana Pauls
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Bldg, 51, rm. 6196
Silver Spring, MD 20993
(301) 796-0518; FAX: (301) 847-8753
e-mail: lana.pauls@fda.hhs.gov
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Date created: May 14, 2008, updated July 28, 2008 |
