An introductory note to the CHMP guidelines: choice of the non-inferiority margin and data monitoring committees In a recent paper published in this journal, Brown et al presented some important features of the European CHMP guideline on the choice of the non-inferior... BLA Hothorn - 《Stati...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.23 (2006) Guidance for clinical trial sponsors: on the establishment and operation of clinical trial data monitoring committees. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126578.pdf U.S. Food...
Meanwhile, a revision proposal of the 'Patent Examination Guideline' was released in February 2013 by SIPO, with a focus on encouraging examiners to conduct a search of prior art for the novelty requirement before granting utility model or design patents. Dr Lui concluded: "Combined with our ...