International Conference on Harmonisation; guidance on data elements for transmission of individual case safety reports; availability. Notice. Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is publishing a guidance entitled "E2B Data Elements for Transmission of Individual Case Safety Reports." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance is intended to facilitate the standardization of the data elements for the transmission of individual case safety reports for both preapproval and postapproval reporting periods.
D003226:Congresses as Topic; D004341:Drug Evaluation / Q000592:standards*; D015507:Drugs, Investigational / Q000009:adverse effects; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D007564:Japan; D008499:Medical Records / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational