This article discusses important aspects of the US Food and Drug Administration’s (FDA’s) “Emerging Technology Program” with a focus on emerging technology, such as continuous manufacturing and 3D printing, and details what information is to be included in drug submissions. The authors highlight a number of benefits of the program, including the synergy created between FDA and the pharmaceutical industry. Introduction An important step in FDA’s mission to support pharma...

This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan. Introduction From clinical trials to marketing authorization, regulatory dossiers for small molecule drug products are incomplete without the presentation of certain regulatory certif...