Our #ICYMI series has looked at some of the best articles that have been written by members of the Acorn Regulatory team. They also present a good opportunity to bring to your attention articles that you might not have seen before and that might be useful to you. This edition of the #ICYMI series looks at well established use, using a US dossier for an European application, how constant changes to legislation and directives can impose additional pressures on regulatory professionals and how new methods of conducting audits can help a company’s bottom line. Directive 2001/83/EC as amended. The choice of legal basis in turn will determine the dossier content, paediatric requirements and data exclusivity. Legal basis is therefore of critical importance from a regulatory perspective. Read more here. Read more here.