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Co-Development Guidance Gives More Attention To IND, NDA/BLA Submissions

 
• By Sue Sutter

In a final guidance on co-development of two or more investigational new drugs for use in combination, FDA lays out general principles for IND and marketing application submissions, a topic on which the agency essentially punted in a December 2010 draft document.

FDA’s final guidelines for co-development of investigational drugs for combination use retain the key principles laid out in a 2010 draft document but provide more extensive instruction to companies on how to submit INDs and marketing applications for such products.

Released June 14, the final guidance, “Co-development of Two or More New Investigational Drugs for Use in Combination,”...

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

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