The U.S. FDA has completed an inspection at Frontage Laboratories clinical research center in Zhengzhou and bioanalytical labs in Shanghai under its new combined clinical trial and bioresearch monitoring program. The two-week inspection took place late February to early March 2013 and supports an ANDAs and NDAs. 
 
No FDA Form 483 notices were issued for the inspection of the bioequivalence study for the ANDA application. One Form 483 was issued for the bioanalytical operations, which Frontage is currently resolving with the agency.
 
“We are pleased that the FDA has approved of our efforts to bring industry-leading drug development practices to China,” said Dr. Song Li, chairman and chief executive officer of Frontage.  “As more pharmaceutical companies seek to expand business in China, they are looking for a company that can provide clinical and bioanalytical research services with globally accepted quality standards. Frontage is the first company to offer such a combination in China that has been inspected by the FDA.”