Attention www.globalkeysolutions.net is now www.keypedia.com, read the full press release here.
KeyPedia LogoKeyPedia Icon
Guidance Documents/Guidance-Document/Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF)

Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF)

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

March 1, 2002

December 1, 2018

Center for Biologics Evaluation and Research

8570d177-c5f6-48b3-9e31-b55fcf3ec212

Related Documents

Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product: Guidance for Industry

Guidance DocumentMarch 8, 1999Center for Biologics Evaluation and Research
View Details →

Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for Industry

Guidance DocumentNovember 1, 1999Center for Biologics Evaluation and Research
View Details →

Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use: Guidance for Industry

Guidance DocumentMay 20, 1999Center for Biologics Evaluation and Research
View Details →

Quick Actions

Your cart

Your cart is empty.

Browse public document pages and click Buy this document. We'll ask for your email at checkout, no account needed up front.

Browse documents

Transform Regulatory Data into Actionable Intelligence

Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.

KeyPedia
Regulatory Data Transformed
Stay in the loop

KRA score changes, company updates and news. About monthly, unsubscribe anytime.

Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
info@keypedia.com
Quick Links
HomePlatform OverviewMedia
KeyPedia™ Lite
Browse HubDatabase DirectoryRecordsCompaniesOfficesPeopleCareersAbout UsFounding TeamMeet Our ExpertsPartners
Legal & Ethics
Privacy PolicyTerms of ServiceOur Values & MissionCode of Ethics & AI Policy
©2026 KeyPedia™ | Global Key Solutions Corp. All rights reserved.