Trade Resources Industry Views The Paragon Report Has Revealed FDA's Consideration

The Paragon Report Has Revealed FDA's Consideration

The Paragon report has revealed FDA's consideration to provide a faster pathway for obesity treatments, life-saving antibiotics and other drugs fit to offer societal benefit.

Under the new pathway, the FDA is expected to allow developers of such drugs to conduct smaller, faster clinical trials and provide a "special medical use" label enabling doctors to administer drugs to critical patients.

The FDA plans have been revealed by its commissioner Margaret Hamburg.

Pew Health Group medical programs deputy director Allan Coukell said a pathway that would allow products to come to market faster and also ensuring they were used only in patients where there was an applicable risk-benefit situation would be good.

"It would be good for developers, for companies and it would be good for public health," Coukell added.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-to-consider-faster-approval-process-for-life-saving-drugs-221012
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FDA to consider faster approval process for life saving drugs