Regulatory Focus™ > News Articles > FDA Sees Huge Opportunities in Opening Up Drug Data

FDA Sees Huge Opportunities in Opening Up Drug Data

Posted 05 December 2011

"LONDON (Reuters) - The Food and Drug Administration (FDA) Commissioner, Margaret Hamburg stated last week at the Financial Times Pharmaceutical and Biotechnology Conference that regulators and drugmakers need to find ways to make more clinical data openly available, since vital knowledge about fighting disease is often locked away in confidential databases.  In particular, making detailed data available on how experimental drugs have performed in clinical tests, which are then filed with regulators, could prevent scientists from pursuing dead-end areas of research, she added.  Hamburg said the pharmaceuticals sector, faced with declining productivity and rising costs in recent years, was now at a critical juncture, requiring greater collaboration and a more imaginative approach by manufacturers. "By opening up some of these databases in careful ways we might be able to benefit the medical product development enterprise overall and ultimately benefit patients," she said." (Reuters)


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Tags: Hamburg, data, drug

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