FDA Lifts Ban on Diagnostic Products

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The U.S. Food and Drug Administration has lifted its ban on reviewing new product applications from Diagnostic Products Corp., the Los Angeles company announced Wednesday.


The company, which makes machines and test kits to detect diseases, allergies and drug abuse, said it received a letter from the FDA lifting the agency’s Application Integrity Policy, which it imposed in December 2003 while it reviewed reported problems with the company’s clinical trial and data collection procedures.


“We are very happy to have this issue successfully resolved,” chief executive Michael Ziering said in a statement.


The Business Journal reported last year that company insiders had sold $3.6

million worth of stock prior to announcement of the FDA probe, prompting investigations by the U.S. Justice Department and the Securities and Exchange Commission.


In addition, the company and its Chinese unit in May agreed to pay a combined $4.8 million to the government to settle allegations that the subsidiary paid kickbacks to officials at government-owned hospitals in China to buy its testing devices.

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