FDA CDER Small Business and Industry Assistance (SBIA) Chronicles

About FDA CDER Small Business and Industry Assistance (SBIA) Chronicles

FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance (SBIA) podcast provides industry with brief synopses of trending regulatory information.

Publisher

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Category

government · health & fitness · science

Language

en

Explicit

No

First episode

26 Feb 2019

Latest episode

13 Dec 2024

Latest episodes

16 episodes in the feed.

1. 

   13 Dec 2024

   Improving Data Quality with Centralized Statistical Monitoring - with Dr. Paul Schuette and Xiaofeng (Tina) Wang

   FDA experts Dr. Paul Schuette and Xiaofeng (Tina) Wang share insights on leveraging centralized statistical monitoring to enhance data quality and efficiency in pharmaceutical development.

2. 

   15 Nov 2024

   Audio Transcript | The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball

   Audio podcast for the pharmaceutical industry on The Need for Artificial Intelligence in Pharmacovigilance and the Emerging Drug Safety Technology Program

3. 

   15 May 2024

   Considerations for Drug Products that Contain Nanomaterials

   Considerations for Drug Products that Contain Nanomaterials

4. 

   18 Aug 2023

   Using Bayesian statistical approaches to advance our ability to evaluate drug products

   Using Bayesian statistical approaches to advance our ability to evaluate drug products

5. 

   11 Jul 2023

   Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products

   Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products

6. 

   10 Apr 2023

   The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

   The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

7. 

   7 Feb 2023

   FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds

   FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds

8. 

   29 Sept 2022

   The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities

   The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities

9. 

   28 Jun 2022

   An FDA Self-Audit of Continuous Manufacturing for Drug Products

   Continuous manufacturing (CM) technology has the potential to improve product quality and reliability, lower manufacturing costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand.

10. 

    20 Apr 2022

    The Key Elements of Being “Recall-Ready”

    A voluntary recall is an action taken by a company to correct a violative product or remove it from the market.

11. 

    3 Sept 2021

    The ABCs of Product Specific Guidances

    Product-specific guidances (or PSGs for short) describe the Agency's current thinking on the evidence needed to demonstrate that a generic drug is therapeutically equivalent to the corresponding reference listed drug (RLD) product.

12. 

    19 Dec 2019

    Improving Regulatory Communication via the CDER NextGen Portal

    The CDER NextGen Portal (or the “Portal” for short) has made it easier than ever for regulated industry to communicate with the FDA.

13. 

    19 Sept 2019

    Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?

    Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA? | September 19, 2019 Issue

14. 

    25 Jun 2019

    Research Investigational New Drug Applications – What You Need To Know

    FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application.

15. 

    23 May 2019

    Competitive Generic Therapies

    Competitive Generic Therapies May 23, 2019 Issue

16. 

    26 Feb 2019

    FDA Modernizes Clinical Trials with Master Protocols

    "FDA Modernizes Clinical Trials with Master Protocols" February 26, 2019 Issue

Reach and audience

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Spotify

5.0 / 5

1 ratings

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Guest appearances

Books guests

Based on episode analysis; this does not confirm that the show is currently accepting guests.