FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials

BioPharma Dive

5 June 2019 - Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the biotech industry mature from the early days of biologics into the drug-developing force it is today.

In the mid-1980s, when Woodcock first started at the FDA, a blue-ribbon commission had been formed in response to an outcry over whether the agency was approving new cancer drugs too slowly.

Now, the debate on how the FDA balances access to new medicines with the need for thorough supporting evidence has reversed. A recently published study, for example, showed only a minority of cancer drug indications approved conditionally during a a 25-year span were subsequently supported with data showing a survival benefit.

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Michael Wonder

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Michael Wonder