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  1. Development & Approval Process (CBER)

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.


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