WASHINGTON -- The FDA will enter into negotiations underwhich Mitre Corp. would become the first company to receivecontracts for external reviews of new drug applications.
The external review program is part of a campaign announcedin November to speed up drug approvals. At the time, theagency said it planned to certify at least three contractors overthe next year to review eight to 12 NDAs where the backlog isgreatest.
Mitre is a systems engineering company based in McLean, Va.,that has civil and defense contracts with several governmentclients. It will manage and oversee the review process, but itwill not actually evaluate the data.
"They will find people to do the reviews, compile informationand send it back to the FDA," said FDA spokeswoman EvaKemper.
Mitre will concentrate on "simpler drugs," such as allergymedications, anti-inflammatory drugs and pain killers,according to Kemper. "They will be doing drugs that we suspectwill not pose any problems," Kemper said.
She said an outside review would be completed in about fourmonths. -- Brenda Deng
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