GFI: Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format

OMB 0910-0771

OMB 0910-0771

The information collection pertains to the submission of periodic safety reports as described in the draft guidance entitled "E2C(R2) Periodic Benefit-Risk Evaluation Report ," which describes the format, content, and timing of a PBRER for an approved drug or biologic. The information collection also pertains to the submission of waiver-related materials as described in the draft guidance entitled "Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format," which informs applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an ICH E2C(R2) PBRER in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations.

The latest form for GFI: Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format expires 2020-11-30 and can be found here.

OMB Details

Applicants that have a Periodic Safety Update Report Waiver for an Approved Application

Federal Enterprise Architecture: Health - Health Care Services


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