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The Ins and Outs of INDs - SYNER-G
The Ins and Outs of INDs - SYNER-G

Expanding Patient Access to Investigational Drugs: Single Patient Investigational New Drug and the “Right to Try” | JACC: Basic to Translational Science
Expanding Patient Access to Investigational Drugs: Single Patient Investigational New Drug and the “Right to Try” | JACC: Basic to Translational Science

Expanding Patient Access to Investigational Drugs: Single Patient Investigational New Drug and the “Right to Try” - ScienceDirect
Expanding Patient Access to Investigational Drugs: Single Patient Investigational New Drug and the “Right to Try” - ScienceDirect

CFRX: IND Application for CF-370 Submitted to FDA…
CFRX: IND Application for CF-370 Submitted to FDA…

Understanding FDA Regulatory Terminology During COVID-19 – Policy & Medicine
Understanding FDA Regulatory Terminology During COVID-19 – Policy & Medicine

DNA to IND – 12 month antibody therapeutic development timeline
DNA to IND – 12 month antibody therapeutic development timeline

Determining if a Study is IND Exempt | Clinical Center Home Page
Determining if a Study is IND Exempt | Clinical Center Home Page

Expanded Access (Compassionate Use) Submission Data | FDA
Expanded Access (Compassionate Use) Submission Data | FDA

FINAL Krauss.Expanded Access Programs
FINAL Krauss.Expanded Access Programs

Project Facilitate
Project Facilitate

Understanding FDA Regulatory Terminology During COVID-19 – Policy & Medicine
Understanding FDA Regulatory Terminology During COVID-19 – Policy & Medicine

Project Facilitate | FDA
Project Facilitate | FDA

Retrospective evaluation of single patient investigational new drug (IND) requests in pediatric oncology - Shulman - 2021 - Cancer Medicine - Wiley Online Library
Retrospective evaluation of single patient investigational new drug (IND) requests in pediatric oncology - Shulman - 2021 - Cancer Medicine - Wiley Online Library

INVESTIGATIONAL NEW DRUG [IND] APPLICATION SUBMISSION (1).pdf
INVESTIGATIONAL NEW DRUG [IND] APPLICATION SUBMISSION (1).pdf

Expanded Access (Compassionate Use) Submission Data | FDA
Expanded Access (Compassionate Use) Submission Data | FDA

Emergency Use | CHOP Research Institute
Emergency Use | CHOP Research Institute

PDF) Expanding Patient Access to Investigational Drugs: Single Patient Investigational New Drug and the “Right to Try”
PDF) Expanding Patient Access to Investigational Drugs: Single Patient Investigational New Drug and the “Right to Try”

Expanded Access to Investigational Drugs - IRB - The University of Utah
Expanded Access to Investigational Drugs - IRB - The University of Utah

Intermediate-Size Patient Populations INDs: What Are They, When Should They Be Used, and Who May Apply for Them?” Richard Klein, Former Director, FDA. - ppt download
Intermediate-Size Patient Populations INDs: What Are They, When Should They Be Used, and Who May Apply for Them?” Richard Klein, Former Director, FDA. - ppt download

Project Facilitate: An Overview of Expanded Access and the Review Process
Project Facilitate: An Overview of Expanded Access and the Review Process

Expanded Access Part 2: How to Submit a Single Patient IND - YouTube
Expanded Access Part 2: How to Submit a Single Patient IND - YouTube

The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza | NEJM
The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza | NEJM

IND Application Process and Best Practices
IND Application Process and Best Practices

Expanded Access Part 2: How to Submit a Single Patient IND - YouTube
Expanded Access Part 2: How to Submit a Single Patient IND - YouTube

Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework | Health Affairs
Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework | Health Affairs