Get The Industry News Roundup for September
In this month’s roundup of industry news roundup, we will be looking at how the USA and Canada are working to align their submission gateways to assist companies making regulatory applications. We will also look at a new EMA drug development document and more.
The U.S. Food and Drug Administration (FDA) has released draft guidance, “Technical Considerations for Additive Manufactured Devices,” leapfrogging the administration’s initial thoughts on 3D manufacturing. The draft guidance outlines technical considerations associated with additive manufacturing processes, testing, and characterization for final finished devices fabricated using additive manufacturing. Read more here.
The Olympics may be over and the focus (in the main) shifted from Rio, but the problems associated with Zika still exist. Forbes magazine has an overview of the problems facing the US government as President Obama asks for$1.9billion to fight the spread of the disease. Read more here.
The US Food and Drug Administration (FDA) has launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.” Read more here.
The main aim of this 2nd revision was to update the guidance on the design of studies in adult patients, especially on potential claims, primary and secondary endpoints, and comparators. It is also intended to give further guidance with regards the possibility for extrapolation from adults, or the need to generate separate data in children and to give recommendations regarding the exploration of PK/PD in paediatric drug development. Read the document in full here.
As part of efforts to further align the US Food and Drug Administration (FDA) and Health Canada, both sides are working to implement a common electronic submission gateway to allow pharmaceutical companies to submit large electronic documents simultaneously to both regulators.
The collaborative effort is just one of a number of joint action plans the two sides are planning as part of the Canada-US Regulatory Cooperation Council (RCC), which aims to increase collaborations between the drug and device regulators. Read more about this development here.