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# Comments Sought on IND Reporting Requirements Extension
- URL: https://www.fdaweb.com/comments-sought-on-ind-reporting-requirements-extension/
- Published: 2016-10-24T12:00:00.000Z
- Updated: 2026-09-14T21:41:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137157

*Federal Register* Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection related to “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.” The document clarifies agency expectations for timely review, evaluation, and submission of relevant safety information and implemented internationally harmonized definitions and reporting standards for IND safety reports. The document also requires safety reporting for bioavailability and bioequivalence studies. To view this notice, click here.