The FDA issues another warning shot on posting clinical trial data 

Last week, the FDA finalized long-awaited guidelines for when regulators will fine companies and universities for failing to submit clinical trial data to ClinicalTrials.gov. The guidance comes on the heels of a federal court ruling in February directing companies and universities to post nearly a decades worth of missing data to the federal repository, as well as a subsequent warning issued in early August from federal regulators that they must post this data as soon as possible. The FDA’s new guidelines were another not-so-subtle push from the agency for companies to fully comply with the law.

“As in all areas that we regulate, our goal is to achieve voluntary compliance with the law,” said FDA deputy commissioner Anand Shah. “However, we intend to hold responsible parties and submitters accountable, including potential legal action, if they are not in compliance.”

If the FDA begins levying fines, it will make waves: The FDA has never levied such a fine.