You are on the new improved site. You can view the old site in view-only mode here until June 27, 2026

Filter Results

Search all journals

Enter search terms…

Advanced search

/

About

About Sage
About Sage Journals
Privacy Policy
Terms of Use
Contact Us
Help

Information for

Authors
Editors
Librarians
Researchers
Reviewers
Frequently asked questions

Copyright © 2026 by Sage Publications.京ICP备09090397号-11

Search results

Search results page

Articles (301)

Journals (0)

1-10 of 301 results for Investigational New Drug Application

Sort by:

Relevance

Select all

Select all

Sort by:

Relevance

Select article: Should Global Clinical Studies be Conducted under the United States Investigational New Drug Application?

Retricted access

Other

First published 2001-4

Should Global Clinical Studies be Conducted under the United States Investigational New Drug Application?

Thomas J. Kirsch, Graham Burton

Therapeutic Innovation & Regulatory Science

Select article: Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

Retricted access

Research article

First published 2009-8

Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

M. E. Blair Holbein

Journal of Investigative Medicine

Select article: An Overview of the Regulatory Approval Process in Drug Development

Retricted access

Other

First published 1998-10

An Overview of the Regulatory Approval Process in Drug Development

Shein-Chung Chow, Annpey Pong

Therapeutic Innovation & Regulatory Science

Select article: Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

Open access

Research article

First published 2014-3

Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

Patrick Archdeacon, Cheryl Grandinetti, José M. Vega [...]

Therapeutic Innovation & Regulatory Science

Select article: An Examination of the Drug Review Process Within the United States

Free access

Research article

First published 1994-04

An Examination of the Drug Review Process Within the United States

Phillip A. Johns

International Journal of Toxicology

Select article: Investigational New Drug Applications: A 1-Year Pilot Study on Rates and Reasons for Clinical Hold

Retricted access

Research article

First published 2016-1

Investigational New Drug Applications: A 1-Year Pilot Study on Rates and Reasons for Clinical Hold

Larissa Lapteva, Anne R Pariser

Journal of Investigative Medicine

Select article: Lessons Learned From a Direct Data Entry Phase 2 Clinical Trial Under a US Investigational New Drug Application

Retricted access

Research article

First published 2012-7

Lessons Learned From a Direct Data Entry Phase 2 Clinical Trial Under a US Investigational New Drug Application

Jules T. Mitchel, Judith M. Schloss Markowitz, Hua (Helen) Yin [...]

Therapeutic Innovation & Regulatory Science

Select article: The Drug Approval Process and the Information it Provides

Retricted access

Other

First published 1987-10

The Drug Approval Process and the Information it Provides

Ann Myers, Steven R. Moore, Abraham G. Hartzema [...]

Annals of Pharmacotherapy

Select article: Pharmaceutical Regulations in the 1980s — Predictions

Retricted access

Research article

First published 1982-4

Pharmaceutical Regulations in the 1980s — Predictions

Jerome A. Halperin

Annals of Pharmacotherapy

Select article: Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis

Retricted access

Research article

First published 2019-1

Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis

Norihito Kohara, Masayuki Kaneko, Mamoru Narukawa

Therapeutic Innovation & Regulatory Science

1
2
3
•••
31
10 / page

Article type

Publication date

Subjects

Access