From May 2017, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically.
It’s a pretty big change – but are you really ready? And do you know how your business can benefit from going paperless?
The FDA has been encouraging electronic submissions for nearly a decade – since 2008 – and it’s easy to see why: some paper-based submissions are tens, even hundreds, of thousands of pages long. It’s an administrative nightmare.
But electronic submissions won’t just benefit the FDA.
Many of the key milestones in the development process already require the production of documentation – especially with the increase in collaboration between organizations. Producing this documentation can take huge amounts of time – think of all the hours spend finding, reformatting, collating/combining and checking data. And that’s before you even consider the significant time and input required from a range of people across multiple organizational functions.
So, what’s the solution?
The key is where you keep your data.
An electronic Development Record (eDR) automatically updates as development progresses, making it a valuable source of information for regulatory submissions, especially electronic ones required by the FDA. That’s one box ticked. And that’s not all…
An eDR reduces, and even eliminates, many data collation and checking activities – saving time, and potentially bringing forward the delivery of a technology transfer dossier by weeks at a time.
With a typical development phase (post early research and prior to clinical trials) accounting for three years and 20-25% of the associated costs of bringing a drug to market, bringing time to market forward by a week can reduce out of pocket expenses by in excess of $6 million. If you’re submitting electronically anyway – which you will be by now– make sure you don’t miss out on the other benefits.