Novel FDA Drug Approvals for 2017

15 June, 2017

Each year, the US Food and Drug Administration (FDA) approves a wide range of new drugs and biological products. The drugs are classified as either new molecular entities (NMEs) or new biologics license applications (BLAs).

In 2016, the FDA’s Center for Drug Evaluation and Research (CDER) approved just 22 novel drugs. This is in comparison to 41 and 45 in 2014 and 2015 respectively.

approvals_chart.jpgHowever, 2017 is shaping up as a bit of a comeback for drug approvals with 21 new drugs already having been approved as of May 26th. Below is a list of drugs approved this year along with the condition they are designed to treat.


What do companies use to share documents with third parties during drug approvals?

ShareVault is ideally suited for sharing sensitive regulatory documents with partners, regulatory advisors, CROs, CMOs and other third parties, including:

  • Electronic Trial Master Files (ETMFs)
  • Investigational New Drug (IND) applications
  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Biologics License Application (BLA)
  • Drug Master File (DMF)
  • Biologics Master File (BMF)
  • Emergency Use Authorization (EUA)
  • Standard Operating Procedures (SOPs)

ShareVault is an easy-to-use, enterprise-grade solution that not only has the best document control features to keep information secure but also includes powerful organizational tools ideally suited for regulatory submissions and other hierarchical document structures.

ShareVault has several features specifically designed for life sciences. For example, ShareVault preserves inter-document hyperlinks which are common in regulatory documents. Most document sharing solutions don't. In addition, ShareVault is the first Virtual Data Room provider to integrate with an eCTD viewer for streamlined viewing of submission documents.

To find out how ShareVault streamlines regulatory secure document sharing, click here