Showing posts with label Combo Products and FDA. Show all posts
Showing posts with label Combo Products and FDA. Show all posts

Tuesday, July 13, 2010

Early Bird Pricing Ends This Friday for the Combination Products Summit

Early Bird Pricing Ends This Friday, July 16th. This is your last chance to register and save $400!

Hear from these and other distinguished leaders at the Combination Products Regulatory & Compliance Summit on September 23-24 in Baltimore to answer your most pressing issues in the industry.

Speaking Faculty includes:
Angela C. Krueger, Regulatory Advisor, CDRH Product Jurisdictional Officer, Office of Device Evaluation, FDA
Understand and Anticipate Combination Product Activity at the FDA

John Kinzell, President & CEO, XERIS PHARMACEUTICALS
Understand and Anticipate Combination Product Activity at the FDA

Eric Edwards, Co-Founder & Chief Scientist, INTELLIJECT
Interpret Auto-Injector Guidance Ambiguities to Compliantly Adapt Best Practices

Michael Gross, Senior Consultant, BIOLOGIC CONSULTING GROUP
Minimize Enforcement Risk Through cGMP Compliance

Asif Sidiqui, Director, Regulatory Affairs, ROCHE MOLECULAR SYSTEMS
Learn What the FDA Looks for in Combination Product Clinical Trials to Avoid Early Life-Cycle Missteps

Suzanne Kiani, Senior Scientist, CMC Regulatory Affairs, GENENTECH
Minimize Enforcement Risk Through cGMP Compliance

View the complete agenda for all speakers and presentations here:
http://bit.ly/cqxdcP

Visit the webpage here:
http://bit.ly/d3J6Hk


Share this article with your social network, just click below to share now!


Wednesday, June 16, 2010

Combo Product submissions to FDA increased in 2009

According to the FDA, Combination Product submissions to the FDA for approval continue to increase. According to the webpage, there were 329 submissions in 2008, which increased to 330 in 2009. Read more about the trends in combination products submissions to the FDA here.



Share this article with your social network, just click below to share now!