WebDATES: Effective Date: These regulations are effective on December 30, 2024. Applicability Dates: For dates of applicability, see §1.162-33(h). FOR FURTHER INFORMATION … WebWithdrawal of IRB Approval. ... Progress toward product approval/clearance, with projected date of PMA or 510(k) submission; Any plans to change the investigation, e.g., to expand the study size ...

Year End Update Adds Ability to Change Sick Pay Anniversary Dates

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IND Application Reporting: Annual Reports FDA

Web1) Prior to the anniversary date, an “Annual Report” is due to the IRB each year during the 3-year approval period. 2) If your protocol will end prior to the end of the 3-year approval period or at the end of the 3-year approval period, a “Final Report” is due to the IRB by the anniversary date. WebIND application sponsors are expected to submit brief reports of the progress of the investigations conducted under their respective IND application within 60 days of the anniversary date that the application went into effect. Such reports are submitted annually and include information listed below. WebIRB Meeting Dates & Deadlines IRB submissions are reviewed on a first-come, first-served basis. If you have a time-sensitive submission, please contact your IRB Review Specialist … lassa tyres review uk