CDER SBIA Chronicles

FDA/CDER SBIA Chronicles, newsletter of the CDER Small Business and Industry 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 CDERSBIA@fda.hhs.gov.

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Title	Date	Podcast
Improving Data Quality with Centralized Statistical Monitoring - with Dr. Paul Schuette and Xiaofeng (Tina) Wang	December 13, 2024	Podcast (12:30 min, 17.2MB, MP3) Transcript
The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball	November 14, 2024	Podcast (11:00 min, 15.1MB, MP3) Transcript
Considerations for Drug Products that Contain Nanomaterials	May 17, 2024	Podcast (11:19 min, 16.2MB, MP3) Transcript

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Archived Chronicles

2015 Chronicles Archive

• "Botanical Drug Review" November 17, 2015 Issue (PDF - 177KB)
• "Drug, Not a Drug, or More?" September 17, 2015 Issue (PDF - 215KB)
• "Import-Export" July 14, 2015 Issue (PDF - 175KB)
• "Patents and Exclusivity" May 19, 2015 Issue (PDF - 187KB)
• "DMF 101" March 19, 2015 Issue (PDF - 132KB)
• "Drugs in Pregnancy and Lactation: Improved Benefit-Risk Information" January 22, 2015 Issue (PDF - 153KB)

2014 Chronicles Archive

• "The Purple Book" November 18, 2014 Issue (PDF - 173KB)
• "Registration and Drug Listing" September 11, 2014 Issue (PDF - 158KB)
• "Drug Shortages – Make an Impact" May 15, 2014 Issue (PDF - 142KB)
• "GDUFA - Where Are We Now?" March 21, 2014 Issue (PDF - 196KB)
• "Improving Drug Supply Chain Integrity" January 22, 2014 Issue (PDF - 130KB)

2013 Chronicles Archive

• "Communicating with CDER" November 14, 2013 Issue (PDF - 120KB)
• "Safety Labeling Changes for Prescription Drugs" September 20, 2013 Issue (PDF - 118KB)
• "USP Salt Policy" July 18, 2013 Issue (PDF - 133KB)
• "BsUFA" May 21, 2013 Issue (PDF - 137KB)
• "Enrichment Strategies" March 14, 2013 Issue (PDF - 138KB)
• "Breakthrough Therapies" January 15, 2013 Issue (PDF - 126KB)

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)