-----Original Message-----
From: U.S. Food & Drug Administration (FDA)
Sent: 11/9/2011 7:48:22 PM
To: guyperea@live.com
Subject: CDER Small Business Update: Introduction to the Drug Master File Webinar
The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
Introduction to the Drug Master File (DMF) Webinar - November 14, 2011
On Monday, November 14, 2011 at 11:00 a.m. (ET), our CDER Small Business Assistance Program will present our webinar entitled Introduction to the Drug Master File (DMF) which will discuss all aspects of filing a DMF, including when and why to submit a DMF; requirements and recommendations for formatting and submitting original DMFs and subsequent submissions; how DMFs are reviewed and common problems.
Our presenter will be Dr. Arthur Shaw who is CDER’s DMF Expert, in addition to being a Quality Reviewer in the Office of New Drug Quality Assessment (ONDQA). He has extensive experience in dealing with DMF filing and database issues, as well as reviewing many DMFs for technical content as part of his daily review work to support New Drug Applications (NDAs) and Investigational New Drug (IND) applications.
Dr. Shaw’s previous positions in FDA include Special Assistant in the Office of New Drug Chemistry and Review Chemist in the Division of Gastrointestinal and Coagulation Drug Products and in the Division of Pulmonary and Allergy Drug Products. Dr. Shaw received a B.S. in chemistry (with Honors) from the City College of New York and a Ph.D. in biochemistry at Cornell University.
Registration website: https://collaboration.fda.gov/dmf/event/registration.html
Web Address for viewing on day of event: https://collaboration.fda.gov/dmf/event/login.html
Call in numbers (listen only mode):
Domestic: 1-800-857-0171
International: 1-517-319-9290
Password (verbal): 2718839
For More Information:
http://www.fda.gov/smallbusinessdrugs
Click on Workshops and Webinars in Spotlight box
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM â€" 4:30PM.
- Email: CDERSmallBusiness@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/smallbusinessdrugs
- Widget: http://www.fda.gov/Drugs/ucm153379.htm
Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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