The ABCs of Product Specific Guidances

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Considerations for Drug Products that Contain Nanomaterials
15 Mai· 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 Aug 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 Jul 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 Apr 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 Feb 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 Sep 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 Jun 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 Apr 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 Sep 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 Dez 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 Sep 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 Jun 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 Mai 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 Feb 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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Folgen

Considerations for Drug Products that Contain Nanomaterials

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

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

The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

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

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

An FDA Self-Audit of Continuous Manufacturing for Drug Products

The Key Elements of Being “Recall-Ready”

Improving Regulatory Communication via the CDER NextGen Portal

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

Research Investigational New Drug Applications – What You Need To Know

Competitive Generic Therapies

FDA Modernizes Clinical Trials with Master Protocols