International Recalls in U.S. by Country
This article was originally published in The Gold Sheet
Listed below are FDA recalls that resulted from drug products or ingredients manufactured outside of the U.S. All but the "believed to be China" category are based on the location of manufacturers cited in weekly enforcement reports FDA issued in 2009. Note: Puerto Rico is listed here even though it is a U.S. territory.
You may also be interested in...
Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.
Using QbD to set specs that make a difference to patients is hard but important work, FDA's Woodcock says. Prasugrel, levothyroxine, pallodone examples explored. How to establish a 'work space.' How to make the right correlations.
As biotech firms begin to pilot QbD they wrestle with FDA over non-critical process parameters, postapproval changes and more. They are exploring how to define design spaces, change them, identify their edges. And they're still wondering what regulatory relief they might get in return for investing in quality-by-design studies.