ABSTRACT
John Barlow Weiner shares some significant considerations reflected throughout this handbook, that may help advance: (i) core regulatory concepts and the critical role that a shared vision has played in their development and translation into regulatory policy and best practices; (ii) the importance of collaboration and coordination to successful shepherding of combination product sponsors and regulators; (iii) two important advances in best practices and regulatory thinking: (a) embracing comprehensive, integrated risk management and (b) focusing on the safety and effectiveness questions raised by combined uses rather than the semantics of “combination product” status, and (iv) how efforts to date can be built upon to facilitate broader adoption of best practices and further convergence and harmonization of regulatory approach across jurisdictions.
