Phase 1 IND Navigator published
FDA released a Phase 1 IND Navigator tool to assist sponsors in preparing and submitting Investigational New Drug applications.
What this means
The FDA's Phase 1 IND Navigator is a resource hub that helps drug developers prepare applications for early-stage human trials of new medicines. Today the agency published updated guidance documents, learning materials, and regulatory references through this online platform. This centralized access to FDA expertise could streamline the process for companies launching first-in-human studies of experimental drugs.
From the source
The Phase 1 IND Navigator provides the tools, guidances, and regulatory expertise you need to prepare and submit an Investigational New Drug application (IND) to FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
Contact Us Questions? Contact the Phase 1 Clinical Trials Support Team: Phone: 240-276-9358 Email: Phase1Questions@fda.hhs.gov
Sub-Topic Paragraphs
Guidance Documents
Search for Phase 1-relevant FDA guidance documents by keyword, topic, center, or product.
CDER and CBER Learning Resources
Conference and webinar presentations, online courses, newsletters and podcasts.
Procedures and Policies
Resources from CDER's Manual of Policies and Procedures (MAPPs) and CBER’s Standard Operating Procedures and Policies (SOPPs)
Chemistry, Manufacturing, and Controls
Learn more about new CDER and CBER Chemistry, Manufacturing, and Controls (CMC) Flexibilities for Phase 1 INDs
Federal Regulations and Regulatory References
Learn more about federal regulations that apply to the IND application process
FDA Actions to Accelerate & Modernize Early and Late-Stage Clinical Development
CBER IND Application Resources
Useful information on the development and submission of INDs from FDA's Center for Biologics Evaluation and Research (CBER)
CDER IND Application Resources
Useful information on the development and submission of INDs from FDA's Center for Drug Evaluation and Research (CDER)
FDA Forms
Search FDA's form database for relevant IND submission forms
Paragraph Header Phase 1 Clinical Trials Support Team
Contact Point
Phase1Questions@fda.hhs.gov
240-276-9358
Hours Available
CDER Division of Drug Information
For Latest Updates Follow
Contact Point Twitter
FDA Drug Information
Receive the latest drug information from the US FDA
Reproduced from FDA Drugs (Whats New) · view original · public domain or open-licensed government work