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    EMA’s Pediatric Committee Seeks to Tweak ICH Q&A on Nonclinical Evaluation of Cancer Drugs

    The European Medicines Agency’s (EMA) Pediatric Committee has offered a couple of comments, slight tweaks and further suggestions for the International Council for Harmonisation’s (ICH) draft question and answer document on its S9 guideline on the nonclinical evaluation for anticancer pharmaceuticals. The committee points to a couple of references in the Q&A on S9 on the scope of the guideline and the statement that "the need for juvenile toxicity testing sho...
  • EMA Releases Guideline for Assessing Human Anticancer Products

    The European Medicines Agency released a new guideline today titled, Guideline on the evaluation of anticancer medical products in man . The guideline, adopted by the EMA during the 15 December 2011 meeting of the Committee for Medicinal Products for Human Use (CHMP), aims to provide guidance on the development of medicinal products for use in anti-cancer indications.  More specifically, the guideline provides clarity on: proper dosing of anticancer products...