OsoBio - The injectables CMO
Regulatory & Supply Chain Management Series

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.

Read the article: The Changing Regulatory Landscape: How drug companies and CMOs can navigate it together

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.

Milton Boyer

Read the series:
We're examining the nature of drug shorts and new ways of CMOs and drug sponsors working together in our newsletters. Our goal is to reduce our mutual risks and surprises with regulatory compliance and in the supply chain.


Meet OsoBio's VP of Quality
David Lee was recently promoted to vice president of quality at OsoBio.  David is responsible for overseeing all quality systems, quality control and manufacturing quality assurance.
He brings to his role more than 20 years of professional experience managing quality operations and API and sterile manufacturing. You can reach David at david.lee@osobio.com.


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