FDA's Data Falsification Proposed Rule Is Overly Strict, Sponsors Say
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency needs to better define the evidence threshold for reporting suspected clinical trial fraud to the agency, industry commenters say.
You may also be interested in...
Generic Labeling Rule Defies Predictions, Remains In FDA's Long-Term Pipeline
Policy that would allow generic sponsors to change product labels has been delayed yet again, not spiked completely, even with Commissioner Gottlieb's known opposition to the rule.
Generic Labeling Rule Defies Predictions, Remains In FDA's Long-Term Pipeline
Policy that would allow generic sponsors to change product labels has been delayed yet again, not spiked completely, even with Commissioner Gottlieb's known opposition to the rule.
FDA Re-evaluating Drug Data Generated By Fraudulent Clinical Investigator
FDA is reviewing data related to drug studies conducted by clinical investigator Robert Fiddes, MD, to ensure the safety and effectiveness of products for which he falsified clinical trial data.