July Drug Product Recalls Feature Teva, Advantage Dose Cases
This article was originally published in The Gold Sheet
Executive Summary
July drug recalls feature concerns about endotoxins that FDA raised with Teva. Meanwhile, the Advantage Dose recall reports continued to roll in by the hundreds.
You may also be interested in...
Propofol featured in October Drug Product Recalls
More propofol recalls announced while FDA lists 37 recalls in October.
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.