Investigational New Drug (IND) Application | FDA
WEBGet to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs.
IND Application Procedures: Overview | FDA
WEBThe current address for sending IND applications may be found at Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs).
IND Applications for Clinical Investigations: Overview | FDA
WEBInvestigational New Drug (IND) Application is submitted to FDA if a drug (or biological product) not previously authorized for marketing in the US is intended to be used for the purposes of...
What is an IND? | Clinical Center Home Page - National Institutes …
WEBMay 8, 2023 · An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
Investigational New Drugs or Biologics | Clinical Center
WEBAn Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. An IND must be authorized prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New ...
eCFR :: 21 CFR Part 312 -- Investigational New Drug Application
WEBGeneral requirements for use of an investigational new drug in a clinical investigation. § 312.41: Comment and advice on an IND. § 312.42: Clinical holds and requests for modification. § 312.44: Termination. § 312.45: Inactive status. § 312.47: Meetings. § 312.48: Dispute resolution.
Understanding FDA Regulatory Requirements for Investigational New Drug ...
WEBStudies using a drug that has not been approved by the Food and Drug Administration (FDA) or for indications not in the approved labeling may require filing an Investigational New Drug (IND) application with the FDA.
eCFR :: 21 CFR Part 312 -- Investigational New Drug Application
WEBAn investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.
Investigational New Drugs or Biologics | Clinical Center Home Page
WEBMay 8, 2023 · What is an IND? An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
IND Applications for Clinical Investigations: Regulatory and ...
WEBMar 7, 2022 · This section is intended to place the clinical development plan for the Investigational New Drug into perspective and to help FDA anticipate the needs of the future program.