The International Conference on Harmonization common technical document--global submission format?
Molzon
Justina A
JA
Center for Drug Evaluations and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, USA.
D004282:Documentation / Q000592:standards*; D004341:Drug Evaluation / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D005060:Europe; D005062:European Union; D006801:Humans; D007390:International Agencies / Q000458:organization & administration / Q000592:standards; D007391:International Cooperation; D007564:Japan; D007880:Legislation, Drug; D014481:United States