Skip to search formSkip to main contentSkip to account menu

Investigational New Drug Application

Known as: Investigational New Drug (IND), Investigational New Drug Applications 
An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application… 
National Institutes of Health

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
2012
2012
Why did Geron—corporate standard bearer for regenerative medicine—fail, whereas technology pioneers in other areas persist? 
2009
2009
The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of… 
Review
2008
Review
2008
The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under… 
Review
2004
Review
2004
PARTIAL CONTENTS Regulatory Practices and Procedures of New Drug, Biologics and Device Development New Product Development Teams… 
Review
1996
Review
1996
Clinical development and regulatory approval times for new chemical entities (NCEs) approved in the United States through 1995… 
Review
1994
Review
1994
This article describes pharmacology and toxicity studies for oligonucleotide drugs that are recommended for inclusion in the… 
1994
1994
In contrast to the well‐defined regulatory requirements for the conduct of animal toxicology studies, FDA regulations and… 
1993
1993
This article focuses on pharmacology and toxicology data that should be included in an Investigational New Drug Application (IND…