New drug takes eight years for approval in the US

January 12th, 2009 - 12:06 pm ICT by IANS  

Washington, Jan 12 (IANS) New drugs being developed for complex diseases might still take eight long years to win US Food and Drug Administration (FDA) approval, according to a study.Although the average time for FDA approval for new drugs declined to 1.1 years in the 2005-07 period, yet combined clinical and approval time continues to hover around eight years, according to Tufts Centre for the Study of Drug Development (Tufts CSDD).

“Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress,” noted Tufts CSDD director Kenneth I Kaitin, in its Outlook 2009 report on pharmaceutical and bio-pharmaceutical trends.

“Still, in drug development, the race - and rewards - go to the swiftest and most efficient drug sponsors, those that can deliver safe and effective new medicines in the shortest time,” Kaitin said.

Among the near-term trends cited in the Tufts CSDD’s Outlook 2009 report are the following:

* Firms will continue globalisation of their pre-clinical and clinical development activities to overcome local capacity constraints, increase speed-to-market, and expand their presence in emerging markets.

* Continued shortages of experienced personnel, especially among upper level managerial staff, will continue to hamper the FDA’s ability to fulfil its mandate, as will advisory committee vacancies depleted by new conflict of interests and public disclosure rules.

* The recent trend of more candidates entering clinical study each year enhances prospects for new monoclonal antibody (mAb) approvals. Currently, 22 mAbs are available in the US and more than 200 are in the pipeline worldwide.

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