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Article: Drug firms failed to start 1,044 Phase IV studies: FDA report.(Post-approval studies)(Food and Drug Administration)(Report)
- Article from:
- Adverse Event Reporting News
- Article date:
- May 6, 2008
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Drug manufacturers have not made progress in starting Phase IV post-approval studies, according to data released April 23, Bloomberg reported.
FDA determined that 1,044, or 62%, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63%, of the unfinished studies hadn't begun, the agency found.
Post-approval studies are often conditions of gaining NDA approval in the first place. Firms often agree to perform additional studies of safety, dosing and other matters after medications come to market. The research is usually voluntary, and lawmakers have repeatedly ...