June Drug Product Recalls
This article was originally published in The Gold Sheet
Executive Summary
June drug recalls feature massive Class II recall by Shreveport, La., repackager Advantage Dose due to cGMP nonconformance, comparable in scale and scope to Actavis Totowa, KV Pharmaceutical, Leiner Health Products recalls of recent years.
You may also be interested in...
Drug Product Recalls In 2009: Categorized By Problem Area
The information on drug product recalls in the following pages has been collected and categorized by "The Gold Sheet" from FDA "Enforcement Reports" issued during calendar year 2009.
McKinsey Survey Highlights Progress, Challenges in Adoption of QbD
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.
Manufacturers Encouraged to Enhance Clinical Relevance of Quality With QbD
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.