What's in an IND? Guide to Writing IND For Biologics
What's in an IND? Guide to Writing IND For Biologics
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What's in an IND? Guide to Writing IND For Biologics

What's in an IND? Guide to Writing IND For Biologics

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Edited Version - Webinar about US Investigational New Drug (IND) Applications.

Edited Version - Webinar about US Investigational New Drug (IND) Applications.

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Writing for Regulatory Submissions and Drug Protection Activities (IND, NDA, BLA, SNDA, ANDA)

Writing for Regulatory Submissions and Drug Protection Activities (IND, NDA, BLA, SNDA, ANDA)

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Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017

Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017

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Webinar about US Investigational New Drug (IND) Applications

Webinar about US Investigational New Drug (IND) Applications

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Vol 48: Navigating the Regulatory Maze: Top CMC Questions to Ace Your IND Application

Vol 48: Navigating the Regulatory Maze: Top CMC Questions to Ace Your IND Application

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Guidance on Preparing an Investigational New Drug Application for Fecal Microbiota...

Guidance on Preparing an Investigational New Drug Application for Fecal Microbiota...

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2019 CCTS FDA Conference - View from Ground Zero: Lessons in Developing Biologic Therapeutics

2019 CCTS FDA Conference - View from Ground Zero: Lessons in Developing Biologic Therapeutics

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Webinar Key Takeaways: Avoiding Common Pitfalls in the IND and CTA Submission Process

Webinar Key Takeaways: Avoiding Common Pitfalls in the IND and CTA Submission Process

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Designing First-In-Human Trials for Small Molecules and Biologics

Designing First-In-Human Trials for Small Molecules and Biologics

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Assembling the Best Team to Navigate through Preclinical Development

Assembling the Best Team to Navigate through Preclinical Development

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What is Investigational New Drug (IND) Application? | Regulatory Learnings | Drug Regulatory Affairs

What is Investigational New Drug (IND) Application? | Regulatory Learnings | Drug Regulatory Affairs

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5 Things You Need to Know About the Drug Approval Process

5 Things You Need to Know About the Drug Approval Process

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Components of New Drug Application and Biologics License Application (5of15) REdI– May 29-30, 2019

Components of New Drug Application and Biologics License Application (5of15) REdI– May 29-30, 2019

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Success Factors in Your IND Filing

Success Factors in Your IND Filing

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Expanded Access

Expanded Access

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Lecture 5, Drug Approval, part 1

Lecture 5, Drug Approval, part 1

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Investigational New Drug Application (IND) Forms: Updates and Best Practices

Investigational New Drug Application (IND) Forms: Updates and Best Practices

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Drug Development after IND: what happens next?

Drug Development after IND: what happens next?

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Navigating FDA: Drug (and Biologic) Development Requirements

Navigating FDA: Drug (and Biologic) Development Requirements

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