FDA Phase IV Website Planned For October 2001; Final Tracking Rule Issued
Executive Summary
FDA plans to launch a website on the status of pharmaceutical company Phase IV commitments by Oct. 1, 2001.
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Phase IV study commitments pending
FDA's Phase IV website will include a database of about 1,700 commitments when it launches, the agency said (1"The Pink Sheet" Oct. 30, 2000, p. 4). FDA will report to Congress that 2,200 of the 3,000 post-marketing commitments in its database are currently outstanding; about 500 involve chemistry studies and, because they are proprietary, will not be included on the public web page. The report was due Oct. 1...