Posted by Michael Wonder on 17 Oct 2016
FDA, EMA officials: regulators must adapt to effectively regulate precision medicine
14 October 2016 - In order to effectively regulate precision medicine, regulators must adapt to alternative methods of evidence generation, say top officials at the US FDA and EMA, as well as the former chair of the UK's MHRA.
The call is made in a commentary published in Nature Reviews: Drug Discovery on Friday by former MHRA Chair Alasdair Breckenridge, EMA Senior Medical Officer Hans-Georg Eichler and FDA's Jonathan Jarow, who serves as senior medical advisor to the center director of the Center for Drug Evaluation and Research.
