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.
Expanded access to a product in an investigational stage 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.
Clinical studies must follow a set of laws and regulations, which are intended to protect the right, 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.
- Submission of an Investigational New Drug Application (IND) to CBER
- Regulatory Submissions in Electronic Format for Biologic Products
- Investigational New Drug (IND) Application
- Expanded Access to Experimental Biologics
- Emergency Use of an Investigational Drug or Biologic
- Expedited Programs
- Regenerative Medicine Advanced Therapy Designation
- INTERACT Meetings (Initial Targeted Engagement for Regulatory Advice on CBER products)
- CBER Advanced Technologies Team (CATT)
- Clinical Investigator Information
- References for the Regulatory Process for the Office of Tissues and Advanced Therapies
- CBER Standard Operating Policies & Procedures (SOPPs)
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
- Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
- Clinical Trial Guidance Documents
- Product Development Under the Animal Rule
Laws and Regulations
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
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