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  1. For Industry

Phase 1 Investigational New Drug (IND) Navigator

Expert Resources. Trusted Support.

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


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Phase 1 IND Resources

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Guidance Documents

Search for Phase 1-relevant FDA guidance documents by keyword, topic, center, or product.
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CDER and CBER Learning Resources

Conference and webinar presentations, online courses, newsletters and podcasts.
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Procedures and Policies

Resources from CDER's Manual of Policies and Procedures (MAPPs) and CBER’s Standard Operating Procedures and Policies (SOPPs)
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Chemistry, Manufacturing, and Controls

Learn more about new CDER and CBER Chemistry, Manufacturing, and Controls (CMC) Flexibilities for Phase 1 INDs
Regulations

Federal Regulations and Regulatory References

Learn more about federal regulations that apply to the IND application process
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FDA Actions to Accelerate & Modernize Early and Late-Stage Clinical Development

Helpful Links

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

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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

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FDA Drug Information

Receive the latest drug information from the US FDA


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