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Investigational Drugs and Devices (IND/IDE) - Harvard …
- https://catalyst.harvard.edu/regulatory/ind-ide/
- As defined by the Food and Drug Administration (FDA), an IND, or investigational new drug application, is a request for authorization from the FDA to administer an investigational drug or biological product to humans. An IDE, or investigational device …
- https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/investigational-new-drug-applications-inds-cber-regulated-products
- 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 …
IND Applications for Clinical Investigations: Regulatory …
- https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-regulatory-and-administrative-components
- IND Applications for Clinical Investigations: Regulatory and Administrative Components IND Applications for Clinical Investigations: Regulatory and Administrative …
Investigational Device Exemption (IDE) | FDA
- https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide
- An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical …
Investigational New Drug (IND) Application | FDA
- https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
Importing Medical Devices | FDA
- https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
- What is a medical device? The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or …
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