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

الحلقات

  1. ٨ مارس

    The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

    The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

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    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.

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  3. ١٥‏/١١‏/٢٠٢٤

    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

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    Considerations for Drug Products that Contain Nanomaterials

    Considerations for Drug Products that Contain Nanomaterials

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

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

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  6. ١١‏/٠٧‏/٢٠٢٣

    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

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

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

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    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

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    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.

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    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.

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    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.

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  12. ٢٦‏/٠٢‏/٢٠١٩

    FDA Modernizes Clinical Trials with Master Protocols

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

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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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