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FDA More Cautious Over Drug Approvals, State Experts

Added October 23rd, 2006

Officials working in the pharmaceutical sector and industry experts have stated that the Food and Drugs Administration is becoming far more careful over the approval of new drugs following the controversy and heat that the agency faced after problems came to light about many approved drugs such as Vioxx.

Experts stated that the FDA is "quietly becoming more assertive about keeping new drugs off the market or refusing to approve new uses for existing medications" and that this is reflected through "numerous unexpected delays and rejections" in relation to new drugs submitted for approval.

One former FDA executive stated: "The uproar that's occurred in the wake of Vioxx has clearly had an effect on the way the FDA approaches its work. The agency doesn't hesitate to say 'No' or 'Send me more data.'"

He also added: "I speak to reviewers, and they all feel very worried that the decisions they make may come back to haunt them". The FDA has come under heavy criticism over recent years because of the various side effects that have come to light with popular drugs such as Vioxx.

FDA More Cautious Over... | Printable Version (Opens In New Window)

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