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November 4, 2022

FDA Modernizes Clinical Trials with Master Protocols | Transcript

Welcome to the CDER Small Business and Industry Assistance (SBIA) Podcast Series  Today’s topic: FDA Modernizes Clinical Trials with Master Protocols  The innovative regulatory approaches resulting […]
November 4, 2022

Transcript: “Competitive Generic Therapies” May 23, 2019 Issue

Welcome to the CDER Small Business and Industry Assistance (SBIA) Podcast Series Today’s topic: Competitive Generic Therapies Drug development can be more challenging for products with […]
November 4, 2022

Transcript: “Research Investigational New Drug Applications – What You Need To Know”

SBIA: 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 […]
November 4, 2022

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

Steve:  Welcome to the CDER Small Business and Industry Assistance (SBIA) Podcast Series Today’s topic: Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA? Determining the […]
November 4, 2022

Transcript: “Improving Regulatory Communication via the CDER NextGen Portal” December 19, 2019 Issue 

Welcome to the CDER Small Business and Industry Assistance (SBIA) Podcast Series Today’s topic: Improving Regulatory Communication via the CDER NextGen Portal  Introduced in 2017, the […]
November 4, 2022

The Key Elements of Being “Recall-Ready” | Audio Transcript

Preparation is key when managing drug product recalls. It is critical for firms to be “recall ready” so that they can act quickly and effectively to […]
November 4, 2022

‘Tantalizing’ New Data for Ibudilast in Multiple Sclerosis ‘Tantalizing’ New Data for Ibudilast in Multiple Sclerosis

Ibudilast has a significant beneficial effect on slowly evolving lesions (SELs) in patients with progressive multiple sclerosis (MS), new data suggest. Through its effect on SELs, […]
November 4, 2022

Mid-October Flulike Illness Cases Higher Than Past 5 Years Mid-October Flulike Illness Cases Higher Than Past 5 Years

Just 3 weeks into the 2022-2023 flu season, the latest data from the Centers for Disease Control and Prevention’s Influenza Division suggest that the flu and […]
November 4, 2022

CDC Officials Want Flexibility in Times of Crisis CDC Officials Want Flexibility in Times of Crisis

Government restrictions hinder the CDC from doing the best possible job in a time of crisis, current and former agency officials are saying. They’re hoping to […]
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