Experts Discuss FDA Inspections in China

“In the future, FDA inspections in China will be multiples of the present level of activity – two, three, four or more times – the point will be to get the job done. The limit will not be restricted by anything except resources,” according to Nicholas Buhay, an FDA Deputy Director. Buhay was speaking to participants in a Webinar, hosted by Windover Information and PharmAsia News entitled “U.S. FDA Inspections in China.” Buhay was joined Raymond A. Bonner, an attorney active in FDA regulatory work at Sidley Austin LLP. “Go back to basics,” Bonner said to companies looking at China partners and worrying about FDA visits. “Think like you would when you do any due diligence. Examine organizational structure and the organization of quality control."  More details...