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The FDA has several special designations or programs to facilitate the development of drugs treating
conditions with an unmet medical need. Certain designations can reduce FDA timelines for reviewing a New Drug Application (NDA) or Biologics License Application (BLA).

With the industry changing so rapidly – along with patient expectations and prescriber priorities – we felt there was an unmet need to shine a light on programs that are leading the way. Transactional features are now table stakes, and going above and beyond with

Tracing is essentially an extension of what companies should already have in place in their suspect drug investigation procedures. The tracing request should not be looked at in a vacuum but as another component of a robust suspect drug investigation.

While Tracing hasn’t gotten much airtime outside the tight circle of DSCSA experts – those of us who live and breathe this – the new Tracing requirement is a fundamental process that will become the norm in the pharmaceutical industry.

Today’s drug pipeline is in an interesting spot. In 2022, there were only 44 novel new drugs approved, down from 58 in 2020 and 60 in 2021. The decrease is due to several reasons beyond a regulatory COVID lag: a constricted approval pathway, the natural

In 2015, the U.S. government passed the 21st Century Cures Act. In it was a provision called the ‘Open Act,’ designed to increase drug pricing transparency by requiring manufacturers to submit clinical trial results and detailed information on production and R&D costs.