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In addition to the three most important elements in any launch, there are a lot more moving pieces to keep track of when you’re putting together your first product launch. Consider this blog as your starting point checklist to help keep things moving as smoothly

A lot of work goes into getting a new pharma product across the finish line, especially if you’re an emerging manufacturer launching your first product. Every element of a launch strategy is important, but certain components outweigh others.

Dive deeper into the nine FDA special designations and programs with Two Labs Drug Pipeline Manager, Ryan Chandanais.

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.