果冻影院

果冻影院 Sponsor-Investigator Training is available on demand 
All 果冻影院 Sponsor-Investigators involved in early-stage research that involve investigator-held IND/IDEs must complete baseline training on regulatory requirements prior to the submission of the initial regulatory application to the FDA. Refresher training must be completed every three years.

Information on requirements related to IND and IDE submissions can be found in the 果冻影院 corporate policy, , RS.GN.170 (intranet access required). 

For additional support, please contact Kristin Busse. 

Access Courses

All 果冻影院-sponsored regulatory submissions to the FDA must be reviewed by the Research Oversight Program prior to submission to FDA, excluding expanded access and emergency use requests. This includes:

• Initial regulatory application submissions associated with a clinical trial (INDs and IDEs)
• Maintenance regulatory submissions (annual or progress reports)

Please submit a service request form for review at least two week prior to the desired FDA submission date. If changes to the submission are identified during review by the Research Oversight Program, revisions to the submission must be made prior to submission to the FDA.

Additional support is offered to investigators needing assistance in navigating complex FDA regulatory pathways. This includes:

• Regulatory submissions and maintenance, including full preparation, electronic submission, and maintenance of regulatory applications to FDA.
• FDA meetings, including preparation scheduling, facilitation of meetings with FDA.
• FDA audit support, including assistance with preparation and implementation of responses to audit observations, in collaboration with the Human Research Protections Program at 果冻影院.

For additional support, please contact Kristin Busse. 

Use the  (PDF) and  (PDF) to determine whether an IDE or IND is required for your study.

For additional support, submit the or contact Kristin Busse. 

FDA information for investigators about submitting Investigational New Drug (IND) applications to FDA. The resources for application reporting and applications procedures apply to IND applications for both clinical research and clinical treatment.

For additional support, please contact Kristin Busse.

Sponsors are responsible for selecting qualified investigators and providing them with the information that they need to conduct the investigation properly. They must also ensure proper monitoring of the investigation and IRB review and approval, submit an IDE application to FDA for significant risk device studies, and inform the IRB and FDA promptly of any significant new information about the investigation.

For additional support, please contact Kristin Busse.

Device Advice, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) web page, for comprehensive regulatory assistance. Device Advice is CDRH's premier text-based resource that explains many aspects of medical device laws, regulations, guidance, and policies, encompassing the entire product life cycle.

For additional support, please contact Kristin Busse.

Find more information on Early Stage Research Regulatory Requirements on the (intranet access required).

For additional support, please contact Kristin Busse.