2018's Most Read Pharmaceutical Articles from Acorn Regulatory

In our end of year series we are looking at the most widely read articles on our website.  This week we are looking at the most read pharmaceutical articles written by our pharmaceutical specialists.  They cover a variety of areas including CMC, strategy, regulatory compliance and more.  You can read some of their most popular articles below.

The US FDA DMF Deadline: 5 Things You Need To Know

The transition from paper based submissions to electronic Common Technical Document (eCTD) has continued in recent years.  This is something that we have covered on this website on a number of occasions.  The next deadline of note is that of the US Food & Drug Administration(FDA) Drug Master File or DMF deadline.  That deadline is May 5th 2018 and right now we are assisting many companies in converting their paper based DMF’s in to the eCTD format.  Read more here.

Is Well Established Use Going Out of Fashion?

John McIntyre looks at one of the most crucial choices Marketing Authorisation Holders must make when submitting a marketing authorisation application (MAA) – the choice of legal basis.  In the European Union (EU), the legal basis of a MAA is laid down in 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.

How Ever-Changing Regulatory Demands Will Impact Small and Emerging Pharmaceutical and Medical Device Companies 

As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In the past, small and emerging life sciences companies might have functioned sufficiently with manual processes and disconnected systems, but may now be unable to satisfy the requirements of regulators whose fundamental shift is a growing focus on electronic processes, data driven decisions and increased transparency to information.   Read more here.

What Are The Common Variation Validation Issues? Find Out Here

Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently approved content of a marketing authorisation which assists in ensuring continued compliance.  We look at the main types of variations and the critical issues that you need to be aware of when completing a variation.  Read more here. If you would like to stay in touch with the latest regulatory and clinical news then subscribe to our newsletter by completing your details below. [ninja_form id=8]