2022年3月31日 · Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs), including: Mailing addresses; Instructions for forms; FDA's receipt of the …

2024年11月18日 · Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs.

Emergency Investigational New Drug (EIND) Applications for Antiviral Products; IND Forms and Instructions; Investigator-Initiated Investigational New Drug (IND) Applications

This template presents the sections that comprise the IND application and was derived from FDA IND regulations (21CRF312.23) and ICH Good Clinical Practice guidelines. Don’t leave a …

The Form FDA 1572 is necessary to include in an initial IND submission and must be filled out when adding a new principal investigator at each site. Please note that a 1572 must be …

The following FDA documents provide an overview of the IND application process: Investigator-Initiated Investigational New Drug (IND) Applications, especially Regulatory and Administrative …

An Investigational New Drug (IND) application is a request for FDA to administer an investigational drug to humans. Sponsors submitting INDs should include Form 1571. For …

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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 …