Drugs
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CDER Small Business Chronicles
FDA/CDER Small Business Chronicles, the monthly newsletter of the CDER Small Business Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation. If you have topics of interest, please email us at CDERSmallBusiness@fda.hhs.gov.
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Latest Issue: "BsUFA" May 21, 2013 Issue [PDF]
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2012 Chronicles Archive
"GDUFA" November 16, 2012 Issue (PDF - 117KB)"PDUFA V" October 12, 2012 Issue (PDF - 140KB)"New Drug Quality" September 17, 2012 Issue (PDF - 725KB)"Unapproved Universe" August 7, 2012 Issue (PDF - 118KB)"Orphan Drugs" July 13, 2012 Issue (PDF - 119KB)"Go Green - Submit Electronically" June 14, 2012 Issue (PDF - 122KB)"IND 101" May 10, 2012 Issue (PDF - 131KB)- "Welcome" - April 12, 2012 Issue (PDF - 707KB)
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