Investigational New Drug Applications (INDs) for CBER-Regulated Products
Welcome to the Investigational New Drug (IND) Application page for products regulated by the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). This page serves as a comprehensive resource for industry professionals involved in the development and submission of IND applications for investigational drugs.
What are INDs?
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Clinical studies are often conducted to collect safety and effectiveness information in support of marketing applications for biologic and drug products. Unless exempted, the sponsor for a clinical study must obtain authorization from FDA for conducting the study by submitting an IND Application. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics Product License Application.
Emergency Use INDs:
Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR , Sec. 312.23 or Sec. 312.20. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
Exception from Informed Consent for Emergency Research
21 CFR 50.24 describes the requirements for conducting planned research to address life-threatening emergent situations in which obtaining prospective informed consent is waived. The research must hold out the prospect of direct benefit to the subjects, the research plan must be approved in advance by FDA and the IRB, and additional protections to the subjects must be included (e.g., consultation with and public disclosure to the communities in which the research will be conducted or from which subjects will be drawn, or both). These clinical investigations are usually not eligible for the emergency approvals described in the other paragraphs on this page. For more information, see guidance, “Exception from Informed Consent Requirements for Emergency Research - Guidance”.
Regulatory Compliance:
Clinical studies must follow a set of laws and regulations, which are intended to protect the rights, safety, and welfare of human subjects participating in human trials, ensure the quality, validity, and integrity of the clinical trial data, and promote the availability of new medical products to the public. These laws and regulations define the roles and responsibilities of entities, such as sponsors, clinical investigators, and institutional review boards. In addition, various guidance documents and standard operating procedures are available to clarify policies and procedures for the IND process.
- Q: When is an IND application required?
A: An IND application is required when a sponsor intends to conduct a clinical study involving the administration of an investigational product to humans, and the study is not exempt from IND requirements. Unless exempted, sponsors must obtain authorization from the FDA by submitting an IND application initiating administration of the investigational product.
- Q: How do I prepare to submit an IND application?
A: Sponsors should compile all necessary information and documentation required for the IND submission, including preclinical data, clinical trial protocols, manufacturing information, and safety monitoring plans. The submission should be prepared according to FDA regulations and guidance documents.
- Q: What are the key components of the IND application?
A: The content and format of an IND submission must be complete, well-organized as per 21 CFR 312, and include all applicable FDA Forms, provided below. These forms can also be found in FDA’s Form Database.
- Form FDA 1571: Investigational New Drug Application
- For Individual patient INDs, a licensed physician may use Form FDA 3926: Individual Patient Expanded Access IND in place of the Form FDA 1571
- Form FDA 1572: Statement of Investigator
- Form FDA 3454: Certification: Financial Interests and Arrangements of Clinical Investigators
- Form FDA 3455: Disclosure: Financial Interests and Arrangements of Clinical Investigators
- Form FDA 3674: Certification of Compliance
- Form FDA 1571: Investigational New Drug Application
- Q: What is Expanded Access to Investigational Products?
A: Expanded access to a product in an investigational stage, therefore not yet approved for commercial use, can be granted by FDA as a compassion measure. These INDs are used for patients with serious diseases outside of clinical trials when no comparable or satisfactory alternative therapy options are available and are requested by the treating licensed physicians who determine whether the benefit outweighs the probable risk. Please see FDA's Final Guidance: Expanded Access to Investigational Drugs for Treatment Use—Questions for more information.
- Q: How do I submit an IND application?
A: How you submit the amendment differs based on the type of IND. Commercial INDs require electronic submission in eCTD format while electronic submission is optional for research / non-commercial INDs. See Investigational New Drug Applications (INDs) for CBER-Regulated Products | FDA.
Commercial IND applications must be submitted electronically through the Electronic Submissions Gateway (ESG) in eCTD format.
Research (non-commercial) IND applications may be submitted electronically through the Electronic Submissions Gateway (ESG). You may also submit via email (150MB max): CBERDCC_eMailSub@fda.hhs.gov
Please note: Although electronic or email submission is preferred, you may submit paper or electronic media (USB drive, CD, DVD) documents and other regulatory correspondence to the Document Control Center at CBER mailing address:
U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002 - Q: What happens after I submit an IND application?
A: After submission, the assigned CBER Regulatory Project Manager (RPM) will acknowledge receipt of the IND application to inform the sponsor that the application has been received. CBER will review the IND application to ensure compliance with regulatory requirements and assess the safety and scientific merit of the proposed clinical studies. The review process may include requests for additional information or clarification from the sponsor.
- Q: When can I initiate a study after I submitted an IND?
A: Only after CBER reviews the IND application within 30 days from the receipt and notifies the sponsor that the study is safe to proceed, the sponsor can initiate the clinical study. If the study is deemed not safe to proceed due to deficiencies, the IND is a subject to a clinical hold.
Please review CBER’s posted SOPP 8217: Administrative Processing and Review Management Procedures for Investigational New Drug Applications for in depth information on CBER’s policies and procedures and understanding on what to expect during initial IND review.
- Q: Have questions related to Coronavirus (COVID-19)?
A: Detailed information is provided in Coronavirus (COVID -19) Related information and Recommendations for Investigational COVID-19 Convalescent Plasma.
- Q: Are you developing Blood Donor Screening?
A: Investigational New Drug (IND) applications often lead to the development of Blood Donor Screening. For further information regarding FDA’s blood standards, please review the Blood Donor Screening website.
- Are you submitting and IND for a drug product regulated by CBER?
A: CBER has traditionally regulated some drug products. For more information on what drug products are within CBER’s jurisdiction, please visit New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products.
If your product is not within CBER’s jurisdiction and regulated by CDER, please find information on submitting your IND to CDER at Investigational New Drug (IND) Application.
- Q: Still have questions? Consider requesting a pre-IND meeting.
A: Pre-IND meetings can be valuable for sponsors in procuring feedback on a sponsor’s product development program, especially if a sponsor’s questions are not fully answered by guidance documents and other publicly available resources. A pre-IND meeting can also provide information that will assist sponsors in preparing to submit complete investigational new drug (IND) applications and reduce the risk of a clinical hold. The primary purpose of this meeting is to review and obtain feedback on the design of preclinical studies, the design of the initial IND study, and product manufacturing and quality controls needed to initiate human studies. The meeting also provides an opportunity to discuss the plans for studying the product in pediatric populations, the target product profile, the quality target product profile, the design and results of any natural history studies, and the best approach for presentation and formatting of data in the IND. For guidance on Scheduling Pre-IND Meetings, please visit: Formal Meetings for CBER-Regulated Products.
IND Review Process:
- Submission of an Investigational New Drug Application (IND) to CBER
- Expanded Access to Experimental Biologics
- Emergency Use of an Investigational Drug or Biologic
- Expedited Programs
- Regenerative Medicine Advanced Therapy Designation
- Product Development Under the Animal Rule
Regulatory Requirements:
- Regulatory Submissions in Electronic Format for CBER-Regulated Products
- CBER Advanced Technologies Team (CATT)
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
- CBER Standard Operating Policies & Procedures (SOPPs)
- Clinical Investigator Information
- References for the Regulatory Process for the Office of Tissues and Advanced Therapies
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
- Clinical Trial Guidance Documents
Relevant Laws and Regulations:
- Proposed & Final Biologics Rules & Notices
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