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August 13, 2003 | In January, McClellan's office released a three-pronged blueprint, called "Improving Innovation in Medical Technology: Beyond 2002," for speeding up and improving drug reviews. Among the elements:


1 Get Drug Reviews Right the First Time. One of the largest sources of delay is so-called multiple review cycles, where after reviewing an application, the FDA asks a company for more information, putting off a ruling on a drug's approvability. McClellan has pushed for better communication between drug companies and the agency before the drug is ever sent to the FDA in an effort to ensure the agency gets all the information it needs the first time.

2 Ensure Top-Notch Reviews. "Improving Innovation" suggests beefing up the standards used to evaluate drug reviewers, including a new set of "good review practices," and calls for increasing reliance on electronic submissions, particularly the electronic common document. Most recently at the BIO 2003 conference, McClellan also called for a comprehensive review of "good manufacturing practices" to permit companies to speedily adopt measures such as Six Sigma quality control.

3 Get It in Writing. McClellan has pushed those working under him to improve the quality and number of the agency's guidance documents, which offer companies a window into current FDA standards and policies. By beefing up the guidance process to handle slippery areas, including cancer, diabetes, and obesity, along with emerging technical issues such as gene therapy and pharmacogenomics, the agency hopes to attract more consistent new drug applications.

Back to Remaking the FDA 





For reprints and/or copyright permission, please contact  Jay Mulhern, (781) 972-1359, jmulhern@healthtech.com.