DIAGNOSTIC PRODUCTS RELEASED FROM FDA'S APPLICATION INTEGRITY POLICY

The FDA has lifted its ban on reviewing new product applications submitted by Diagnostic Products (DPC), the Los Angeles-based test kit manufacturer announced.

The agency slapped DPC with an Application Integrity Policy (AIP) in December 2003 after uncovering possible problems with the company's clinical trial and data collection procedures. The AIP suspended the FDA's review of the DPC's pending diagnostic test applications and deferred scientific review of any future submissions until the problems were resolved.