By now, recurring shortages of injectable drugs have attracted everyone’s attention – including that of the U.S. Food and Drug Administration, whose officials have enacted new regulations intended to reduce shortages.
Whether one agrees or disagrees with the new FDA regulations, no one can dispute that the changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations.
In this latest chapter in OsoBio’s ongoing newsletter series about how shortages are affecting the parenteral pharmaceutical industry, I’ll examine some of these relationship changes in more detail.
Mind you, these are my observations – and in exchange, I’d like to hear about yours, because yours might be different. And it is in understanding and appreciating different perspectives that we, as an industry, can develop sustainable solutions to our common problem of drug shortages.
So, let me hear from you. You can comment at the end of the article or contact me personally. I would welcome the discussion.