Data on Offshore Manufacturing
Over 80% of APIs are now sourced from counties outside of the US, including from developing countries. As such, drug quality has become more difficult to control. Drug manufacturing plants in the US, owned by US-based manufacturers, are sometimes plagued by quality concerns. Yet, because of the highly-regulated environment and the transparency with which US and European firms operate, consumers have high expectations of quality from products manufactured in the US and Europe. Quantifying the risks associated with offshore manufacturing, and identifying its causes are important steps in controlling the quality of drugs that come from widely-dispersed facilities. Read more »
In just a few weeks, the PDA-FDA Joint Regulatory Conference is taking place in Washington, DC. Between 800 and 1000 attendees are expected, including good representation from FDA. I spoke with Susan Schniepp, co-chair of the meeting, vice-president of quality for OSO Biopharmaceuticals, and a member of PharmTech’s Editorial Advisory Board, to see what participants can expect this year. 
As Congress returns from summer recess, and national campaigns begin, job creation is undoubtedly the theme for the near term. Debates over the role of government in stimulating economic growth through fiscal and regulatory policy are inviting opinions from all sides of the political spectrum. Despite all the contention that is and will continue to ensue, there is generally one agreed-upon precept: innovation is a valuable tool to create and sustain economic growth. But how does the quest for innovation square with government regulation? That debate is taking shape not only broadly but in the nascent field of synthetic biology, where scientific, public-health, and business interests are converging. 