Clinical Researcher Debarments Proceeding Slowly, Despite FDA Promises Of Reform
This article was originally published in The Pink Sheet Daily
It still takes years to debar a physician convicted of a crime from conducting clinical research.
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FDA pending actions include proposed rules on the handling of citizen petitions, eligibility for orphan drug designation and post-market safety reporting for combination products.
The agency will revise its regulations to prevent clinical investigators who are disqualified from running trials for one product type to continue leading studies for other FDA-regulated categories.
Recent changes will speed FDA's process for barring non-compliant clinical trial investigators from future product research, agency staffers say