The FDA has released a list of almost 100 draft drug guidance documents it plans to introduce or update in 2015. The documents cover a range of biotech IT-related topics, including electronic informed consent in clinical trials, links to third-party sites in social media adverts and statistical approaches to showing biosimilarity.
The list provides a snapshot of some of the ways in which IT is troubling and helping the FDA and the industry it regulates. In many areas technological advances have outstripped the pace of regulatory guidance, something the FDA is trying to address in 2015. Clinical trial sponsors should get greater clarity on the FDA's attitude toward electronic informed consent--an approach Shire ($SHPG) and others have been trialling for several years--when the regulator releases a draft Q&A document on the topic.
The FDA is also set to continue drip feeding social media guidance to the industry. The latest document to come down the regulatory pipeline covers the use of links to third-party sites in adverts on social media and other online platforms. The FDA is also working through the feedback to the long-awaited Twitter ($TWTR) guidance, which prompted concerned reactions from the likes of BIO and PhRMA when it was published last year.
The rest of the FDA's IT-related draft guidance documents cover the evaluation of analytical similarity data--a topic that will grow in importance now it is set to start approving biosimilars--and electronic submissions. In February, the FDA decided to break up its guidance on electronic submissions into multiple documents, three of which are scheduled for publication in 2015. The three documents cover manufacturing establishments, bioanalytical methods and bioresearch monitoring inspections.
- read the list (PDF)