title: International Conference on Harmonisation; final recommendation for the revision of the permitted daily exposure for the solvent cumene according to the maintenance procedures for the guidance Q3C Impurities: Residual Solvents; availability. Notice.
abstract: The Food and Drug Administration (FDA) is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ``Q3C Impurities: Residual Solvents.'' The recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
mesh_terms: D001555:Benzene Derivatives / Q000592:standards*; D002273:Carcinogens / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence*; D003226:Congresses as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry; D005062:European Union; D006801:Humans; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D007564:Japan; D008452:Maximum Allowable Concentration; D012997:Solvents / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001555:Benzene Derivatives; D002273:Carcinogens; D012997:Solvents; C015763:cumene