miércoles, 1 de abril de 2015

2015 REdI Generic Drugs Forum (4/22-4/23) - Important Agenda and Registration Information

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
Generic Drug Forum
April 22-23, 2015 
The Sheraton Silver Spring Hotel
Silver Spring, MD
We are only three weeks away from our first ever Regulatory Education for Industry (REdI): Generic Drugs Forum. We urge you to take advantage of this opportunity to interact with FDA subject matter experts as we discuss various topics along the dynamic continuum of the generic drug approval process.  Though this event is FREE, advance registration is required. Once you register, you may attend either in person or virtually. 
Visit our webpage for a complete AgendaTopics include:
  • Current Regulatory Practice in Type II API DMF Review
  • Update on Question-based Review (QbR) 
  • Proper Regulatory Submission During the Lifecycle of Generic Drug Products

Hope to see you there!

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry 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 CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

Please take our CDER SBIA survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation

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