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

11 июл 2023 · FDA CDER Small Business and Industry Assistance (SBIA) Chronicles

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

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Considerations for Drug Products that Contain Nanomaterials
15 мая· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Considerations for Drug Products that Contain Nanomaterials
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Using Bayesian statistical approaches to advance our ability to evaluate drug products
18 авг 2023· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Using Bayesian statistical approaches to advance our ability to evaluate drug products
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Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
11 июл 2023· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
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The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
10 апр 2023· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
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FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
7 фев 2023· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
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
29 сен 2022· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
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
28 июн 2022· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
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”
20 апр 2022· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
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
3 сен 2021· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
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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Improving Regulatory Communication via the CDER NextGen Portal
19 дек 2019· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
The CDER NextGen Portal (or the “Portal” for short) has made it easier than ever for regulated industry to communicate with the FDA.
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Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?
19 сен 2019· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA? | September 19, 2019 Issue
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Research Investigational New Drug Applications – What You Need To Know
25 июн 2019· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
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.
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Competitive Generic Therapies
23 мая 2019· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
Competitive Generic Therapies May 23, 2019 Issue
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FDA Modernizes Clinical Trials with Master Protocols
26 фев 2019· FDA CDER Small Business and Industry Assistance (SBIA) Chronicles
"FDA Modernizes Clinical Trials with Master Protocols" February 26, 2019 Issue
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