Investigational New Drug (IND) Application | FDA
2024年11月18日 · FDA IND, NDA, ANDA, or Drug Master File Binders Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well …
IND Application Procedures: Overview | FDA
When submitting original IND applications, sponsors are expected to send their applications in triplicate (one original and two copies). Electronic submissions should be considered whenever ...
IND Applications for Clinical Investigations: Overview | FDA
Investigational 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 ...
IND Forms and Instructions - FDA
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 IND
Investigator-Initiated Investigational New Drug (IND) Applications
This table provides links to information for investigators about submitting Investigational New Drug (IND) applications to FDA. The resources for application reporting and applications procedures ...
Submission of an Investigational New Drug Application (IND) to …
2023年9月29日 · 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 …
IND Activity | FDA - U.S. Food and Drug Administration
On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.
Information for Sponsor-Investigators Submitting INDs
An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans.
Drug and Biologic Approval and IND Activity Reports | FDA
2019年10月17日 · The list below includes links to Center for Drug Evaluation and Research new drug and biologic approval reports. These reports contain information on new drug application …
Investigational New Drug Applications (INDs) for CBER-Regulated ...
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.