Proposed Methodologies for Reviewing Clinical Data by Remote Access

Abstract

Prompted by a host of pressures challenging the timeliness of the FDA's process for reviewing pharmaceutical products for marketing approval, the Center for Drugs and Biologics, in cooperation with volunteering pharmaceutical firms and industry support organizations, is investigating the feasibility of several different activities aimed at finding optimizations for its review methodology. This article will describe several of these different activities, discussing methodologies proposed and various preliminary expectations. For those pilot activities already in progress, some experiences already gained will be shared. For activities not yet begun, some comments regarding structure and expectations will be stated. Other ideas for future efforts, where there may be potential benefits for both the government and for industry, will be provided.