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  1. CDER Small Business & Industry Assistance (SBIA)

 

CDER Small Business & Industry Assistance (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
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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