US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’
Acting FDA commissioner says there are a lot of strong forces in the research and pharma industries that could curb efforts to make pandemic-related clinical trial reforms permanent.
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Remote Monitoring Next Front For Regulatory Flexibility, But Will Some Accelerated Approvals Ever Be Confirmed?
Former OTAT Director Wilson Bryan says rare disease development will advance thanks to remote monitoring tools, but questions whether the long times needed to confirm clinical benefit for some drugs or biologics could come at the expense of better products.
Even if the agency had the legal power, it likely did not have the resources to oversee all clinical trials, rather than only those that qualified under the IND regulations, but the extra oversight could have increased coordination and ensured more data was fit for regulatory purposes.
With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.