The US Food and Drug Administration (FDA) is apparently continuing to slow its withdrawal procedure for a drug that was granted access to the market through the agency's accelerated approval process.
The accelerated approval process for prescription drugs remains a problem for the US Food and Drug Administration, some observers say. For such approval, the FDA expects the drug maker to conduct postmarket studies to evaluate the drug's clinical benefits and adverse events, but companies often do not do such studies in a timely manner.
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