Day: February 8, 2024

The concept of quality by design (QbD) has been used primarily in the context of GMP compliance. However, the FDA expects that this concept should be used in other compliance areas as well, particularly clinical trials. FDA and Duke University recently held a workshop describing various aspects of clinical trials that could be improved by … Read more

This week the US House of Representatives held a hearing on the lack of foreign on-site GMP inspections by the FDA where representatives from the GAO and other stakeholders including a “star witness” from India, presented their concerns about the quality of drugs imported into the US. The speakers and the committee members seemed to … Read more