FDA CDER Small Business and Industry Assistance (SBIA) Chronicles

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

  1. 13 DE DEZ.

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

    Listen to Tina Wang, Statistician, and Dr. Paul Schuette, Deputy Division Director, in the Office of Biostatistics Division of Analytics and Informatics within FDA’s Center for Drug Evaluation and Research discuss FDA’s experiences with a centralized statistical monitoring tool.

    13min

  2. 15 DE NOV.

    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

    11min

  3. 15 DE MAI.

    Considerations for Drug Products that Contain Nanomaterials

    Considerations for Drug Products that Contain Nanomaterials

    11min

  4. 18/08/2023

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

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

    8min

  5. 11/07/2023

    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

    8min

  6. 10/04/2023

    The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

    The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

    10min

  7. 07/02/2023

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

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

    11min

  8. 29/09/2022

    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

    7min
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FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance (SBIA) podcast provides industry with brief synopses of trending regulatory information.

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