Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."

We think this move strongly suggests that the agency may be getting serious about enforcement of the ClinicalTrials.gov regulations and may be planning to crack down on companies that fail to comply with the clinical trial registration, results posting, and certification requirements.

Read More: Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures


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