Electronic Submissions; Update to the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports for Vaccines; Technical Specification
The Food and Drug Administration (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing the availability of version 2.3 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRS) for Vaccines (Specifications). The version update is not applicable to CBER- regulated drug products marketed for human use with approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs); CBER-regulated therapeutic biological products marketed for human use with approved Biologic License Applications (BLAs); Whole Blood or blood components; and human cells, tissues, and cellular and tissue- based products (HCT/Ps) regulated solely under the Public Health Service Act.
Abstract as published in the Federal Register.
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