FDA’s New Pharma Quality Office Will Take a Team Approach: Yu Explains By Ed Silverman

• By
 
• ED SILVERMAN

FDA

Having spent two years exploring ways to bolster manufacturing standards and improve the overall quality of medicines, the FDA this week officially opened its new Office of Pharmaceutical Quality. The effort is still a work in progress – a few key elements are not yet finalized. But agency officials hope that, by integrating functions performed by staffers who review drug applications and inspectors who visit manufacturing plants, there will be fewer glitches as medicines come to market. We spoke with Lawrence Yu, the OPQ deputy director, about the concept and the work to be done. This is an excerpt. more