Electronic Submission Capability to FDA for Academic Investigators-The Process, Challenges, and Opportunities Affecting the Translational Research Enterprise-Reference-Cited by-同舟云学术

Electronic Submission Capability to FDA for Academic Investigators-The Process, Challenges, and Opportunities Affecting the Translational Research Enterprise

Published:2013-11-06 Issue:1 Volume:7 Page:63-68
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical And Translational Science

Author:

Seymour E Mitchell¹,Azevedo Antoinette²,Wright Jeanne K.¹,Reisdorph Bill R.¹,Moore Mona¹,Weatherwax Kevin J.¹

Affiliation:

1. Michigan Institute for Clinical and Health Research IND/IDE Assistance Program; Ann Arbor Michigan USA

2. e-SubmissionSolutions.com and Sage Submissions; San Diego California USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Reference12 articles.

1. FDA Guidance for Industry. Providing Regulatory Submissions in Electronic Format- Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications 2013

2. FDA eCopy Program for Medical Device Submissions 2012 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM313794.pdf

3. A program to provide regulatory support for investigator-initiated clinical research;Arbit;Acad Med: J Assoc Am Med Coll.,2006

4. FDA Content and Format of Investigational New Drug Applications (INDs) for Phase1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology- derived Products 1995 http://www.fda.gov/downloads/Drugs/.../Guidances/ucm074980.pdf

5. FDA FDA Portable Document Format (PDF) Specifications Version 3.1 2012 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163565.pdf