Phase 1 IND Learning Resources
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Find links to FDA learning resources related to Phase 1 IND applications.
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Questions? Contact the Phase 1 Clinical Trials Support Team:
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Email: Phase1Questions@fda.hhs.gov
Learning Resources for CBER-regulated Products
- Investigational New Drug Applications (INDs) for CBER-Regulated Products
- CBER's Policies, Procedures, and Review Resources for Industry
- CBER Office of Therapeutic Products (OTP) Learn
- CBER Workshops, Meetings, and Conferences
Learning Resources for CDER-regulated Products
- Investigational New Drug Applications (INDs) for CDER-Regulated Products
- CDER Small Business and Industry Assistance (SBIA) Learn
- Drug Development and Review Definitions
- CDER Meetings, Conferences, and Workshops
Phase 1 IND On Demand Learning Library
Basics of Clinical Trial Design (2024)
Learn the essential principles behind rigorous clinical research that supports FDA drug approvals. This video covers the key elements that make clinical studies reliable and scientifically sound, including what makes a study "adequate and well-controlled" according to FDA standards. Explore why control groups are critical for determining drug effectiveness, examine different types of controls used in clinical investigations, and discuss proven methods researchers use to minimize bias and ensure objective results.
Safety Considerations in Clinical Drug Development (2024)
Discover the critical safety principles that guide the earliest stages of human drug testing. This video emphasizes why participant protection must always be the top priority when designing initial clinical studies and explores the unique safety challenges researchers face in phase 1 trials. Topics discussed include essential safety considerations specific to first-in-human studies, how continuous safety monitoring protects participants throughout the trial process, and the reporting requirements that ensure regulatory oversight and transparency.
Specific Populations in Clinical Trials (2024)
Explore the critical importance of including diverse populations in clinical research to ensure medications are safe and effective for everyone who will use them. This video examines the unique considerations for including children in drug development studies, addressing the special protections and scientific approaches needed for pediatric research. The presentation discussed the complex challenges and evolving approaches to studying medications in pregnant and lactating women, balancing maternal and fetal safety with the need for evidence-based treatment options. Additionally covered were strategies for enhancing overall diversity in clinical trials to ensure research findings are applicable across different demographic groups.
Chemistry, Manufacturing and Controls: Regulatory Considerations and Resources (2024)
This presentation examines regulatory definitions and requirements for drug substances and drug products in IND submissions. The session describes essential Chemistry, Manufacturing, and Controls (CMC) information required for IND applications and identified potential CMC safety concerns that may arise during investigational drug development. The discussion provided practical guidance for understanding regulatory expectations and ensuring appropriate CMC documentation for successful IND submissions.
Pharmacology & Toxicology in the Investigator’s Brochure (2024)
This presentation describes the types of nonclinical information required in the Investigator's Brochure (IB), covering pharmacology, safety pharmacology, and pharmacokinetics/ADME studies. The session examined toxicology requirements including general toxicology, genetic toxicology, and reproductive toxicology studies. The discussion familiarized attendees with relevant International Council for Harmonization (ICH) and FDA guidance documents, providing comprehensive insights into nonclinical data requirements for clinical trial documentation.
Clinical Pharmacology: Early Drug Development (2024)
This presentation defined clinical pharmacology and examined its critical role in early drug development. The session provides an overview of early clinical studies, including timing considerations, goals, and key design elements, while covering the information gained from these studies. The discussion explored physiologically-based pharmacokinetic (PBPK) modeling and model-informed drug development approaches, offering insights into how clinical pharmacology supports efficient drug development strategies.
Innovative Approaches to Clinical Trials (2024)
This presentation explores how electronic technologies are revolutionizing clinical trial design and execution through digital innovations in information exchange, remote data collection, and enhanced clinical measurements. The session examined interoperable electronic systems that integrate clinical care with research and discussed how technological advances improve trial efficiency, patient convenience, and access for diverse populations including those with rare diseases. The discussion provided insights into digital transformation's impact on research quality and participant accessibility.