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FDA Inspects Frontage Site in China

New program combines clinical trial and bioanalytical activities

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 i...

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