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FREQUENTLY Asked Questions
Which FDA office may an IRB contact to determine whether an investigational new drug application (IND) or investigational device exemption (IDE) is required for a study of a test article?
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contact the Center for Drug Evaluation and Research (CDER), Office of Communications, Division of Drug Information at (301) 796-3400
contact the Center for Biologics Evaluation and Research (CBER), Office of Communication, Outreach and Development, at (800)-835-4709 or (301) 827-1800.
contact the Investigational Device Exemption (IDE) Staff, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), at (301) 796-5640.
Investigational Device Exemption (IDE)
Institutional Review Boards (IRB)
Investigational New Drug Application (IND)
What IRB records are required for studies that are approved but never started?
Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval?
How does the non-local IRB obtain knowledge of local community attitudes, conditions surrounding the conduct of the research, and the continuing status of the research?
To what extent is the IRB expected to actively audit and monitor the performance of the investigator with respect to human subject protection issues?
How can a sponsor know whether an IRB has been inspected by FDA, and the results of the inspection?
The number of studies an IRB reviews has increased, and the size of the package of review materials sent to IRB members is becoming formidable. Must the IRB send the full package to all IRB members?
How can informed consent be obtain from non-English speaking subjects?
What are the IRB's general obligations towards intraocular lens (IOL) clinical investigations? Considering the large number of IOL studies, how does an IRB approach the review of a new IOL style?
Do Radioactive Drug Research Committees (RDRCs) have authority to approve initial clinical studies in lieu of an IND?
May a clinical investigator be an IRB member?
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