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HHS Report Rips FDA's Human Subject Protection Efforts and Lack of Site Audits

The U.S. Food and Drug Administration (FDA) audited fewer than 1% of investigative sites, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, found in a report released Friday. The 41-page report said the FDA has just 200 specially-trained inspectors to audit an estimated 350,000 investigative sites. Others estimate that the number of sites is much lower. The report found that federal health officials did not even know how many clinical trials were being conducted in the U.S. According to CenterWatch, an estimated 59,000 drug trials, phases I, II and III, were being conducted worldwide in 2006.

PDUFA Revitalization Act to Boost Post-Approval Sector

Congress' recent reauthorization of the U.S. Food and Drug Administration's (FDA) Prescription Drug User Fee Act (PDUFA) included a series of changes that will no doubt have profound effects on the clinical trials industry. Enacted in 1992, PDUFA needs to be renewed every five years. It was set to expire on Sept. 30. It allows the FDA to collect fees from drug and device companies applying for regulatory approval. The new bill calls for an increase in those submission fees to bolster FDA’s drug safety review and post-approval monitoring initiatives, much of which were created after a series of high profile recalls and safety issues. Under the bill, pharmaceutical developers would pay nearly $400 million and medical device makers $48 million in fees next year, a 25% increase.

Other breaking news...      

• invivodata in contract with Dainippon Sumitomo...
• AstraZeneca KK signs agreement with Keio University School of Medicine...

Company Profile: An interview with Murray Jensen, director of clinical and scientific affairs; Martin Letendre, director of ethics and legal affairs; Ramesh Chouhan, president (technical), Matrix Group;ethica Clinical Research, ethicamatrix.

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