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The FDA is stepping up its efforts to get pharmaceutical companies to submit more complete applications for new molecular entities (NMEs) — an action the agency believes could expedite the drug approval process.
The FDA has signed a contract with an independent consultant to examine why first-cycle drug reviews fail, the head of the Center for Drug Evaluation and Research (CDER) said last week at the Biotechnology Industry Organization’s annual convention in San Francisco.
The FDA has signed a contract with an independent consultant to examine why first-cycle drug reviews fail, the head of the Center for Drug Evaluation and Research (CDER) said late Tuesday at the Biotechnology Industry Organization’s annual convention in San Francisco.
The number of adverse events reported to the FDA’s Center for Drug Evaluation and Research (CDER) increased 15 percent last year largely due to electronic filing of adverse event reports, according to the center’s chief.
Rather than curtailing services, the FDA plans to consolidate the agency’s 16 existing drug review centers into just three centers at the White Oak campus in Maryland, which should increase productivity and boost performance, according to an FDA spokesperson.
Applications are still being accepted by several Center for Drug Evaluation and Research (CDER) product review divisions for a pilot program to assess the effectiveness of continuous marketing applications for fast-track designated drugs, the agency announced last week.
More than half of the participating product review divisions in the FDA's Center for Drug Evaluation and Research (CDER) are still accepting submissions for a pilot program that will assess the effectiveness of continuous marketing applications for fast-track designated drugs, the agency announced recently.
The Center for Drug Evaluation and Research (CDER) has updated mailing addresses for a variety of biological therapeutic product submissions, the center announced Feb. 13.
The FDA would get $1.8 billion in fiscal 2005, with the lion’s share of the $149 million increase over last year’s appropriations going to food safety rather than toward programs affecting the drug industry, according to details of President Bush’s proposed budget that was released last week.