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
Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products	August 17, 2023	Podcast (7:30 min, 10.3MB, MP3) Transcript
Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products	July 10, 2023	Podcast (7:58 min, 7.31MB, MP3) Transcript
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development	April 10, 2023	Podcast (9:48 min, 13.5MB, MP3) Transcript
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds	February 6, 2023	Podcast (11:28 min, 10.5MB, MP3) Transcript
The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities	September 29, 2022	Podcast (7:09 min, 6.54MB, MP3) Transcript
An FDA Self-Audit of Continuous Manufacturing for Drug Products	June 28, 2022	Podcast (11:12 min, 10MB, MP3) Transcript
The Key Elements of Being “Recall-Ready”	April 19, 2022	Podcast (7:51 min, 7.4MB, MP3) Transcript
The ABCs of Product Specific Guidances	September 2, 2021	Podcast (7:23 min, 6.8MB, MP3) Transcript
Improving Regulatory Communication via the CDER NextGen Portal	December 19, 2019	Podcast (6:01 min, 6.8MB, MP3) Transcript
Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?	September 19, 2019	Podcast (7:48 min, 9.6MB, MP3) Transcript
Research Investigational New Drug Applications – What You Need to Know	June 25, 2019	Podcast (4:58 min, 6.8MB, MP3) Transcript
Competitive Generic Therapies	May 23, 2019	Podcast (6:49 min, 9.49MB, MP3) Transcript
FDA Modernizes Clinical Trials with Master Protocols	February 26, 2019	Podcast (5:34 min, 5.1MB, MP3) Transcript

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Archived Chronicles

2018 Chronicles Archive

• "Early Engagement with FDA to Discuss Novel Surrogate Endpoints" November 27, 2018 Issue
• "FDA Facilitates the Use of Surrogate Endpoints in Drug Development" November 5, 2018 Issue
• "Real-Time Review of Drug Applications is Now a Reality" September 20, 2018 Issue
• "The FAERS Public Dashboard and its Value to the Pharmaceutical Industry" July 10, 2018 Issue
• "A New Era for Homeopathic Drug Product Regulation" March 22, 2018 Issue
• "FDA Helping the Generic Industry Submit Complete Applications" February 6, 2018 Issue

2017 Chronicles Archive

• "PDUFA VI - A Time for Change" November 28, 2017 Issue
• "Real-World Data and Evidence in Drug Development" 8/24/2017 Issue
• "Submitting Master Files in eCTD Format: When and How to Comply" 5/25/2017 Issue
• "The Complexities of Compounding" 4/20/2017 Issue
• "FDA Addresses Small Business Concerns in GDUFA II" 1/26/2017 Issue

2016 Chronicles Archive

• "FDA’s Quality Metrics Reporting Program and the voluntary submission of Quality Metrics Data" November 30, 2016 Issue (PDF - 157KB)
• Audio: FDA’s Quality Metrics Reporting Program and the voluntary submission of Quality Metrics Data
• "FDA Requires Use of eCTD Format and Standardized Study Data in Future Regulatory Submissions" September 22, 2016 Issue (PDF - 175KB)
• Audio: FDA Requires Use of eCTD Format and Standardized Study Data in Future Regulatory Submissions
• "User Fees and the Future of the OTC Monograph System" July 6, 2016 Issue (PDF - 160KB)
• Audio: "User Fees and the Future of the OTC Monograph System" July 6, 2016 issue abridged (MP3 - 8.1MB)
• "FDA Embraces Emerging Technology for Bioequivalence Evaluation of Locally Acting Nasal Sprays" May 19, 2016 Issue (PDF - 185KB)
• Audio: FDA Embraces Emerging Technology for Bioequivalence Evaluation of Locally Acting Nasal Sprays abridged (MP3 - 4.5MB)
• "FDA Embraces Emerging Technology for Bioequivalence Evaluation of Locally Acting Nasal Sprays" May 19, 2016 Issue (PDF - 185KB)
• "FDA's Office of Pharmaceutical Quality - ONE YEAR IN" April 4, 2016 Issue (PDF - 166KB)
• "Best Communications Practices with FDA" January 21, 2016 Issue (PDF - 210KB)

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)