Importance Of Quality Data In Meeting Increasing FDA Regulatory Scrutiny

Developing and launching a new drug, vaccine, gene therapy, or medical device often comes with a hefty price tag, totaling $48 million on average. With so much money and time invested, it is crucial for research teams to meet all regulatory criteria and ensure data quality, as failure to do so can result in the failure of an entire trial.

While rigorous regulatory scrutiny is not new, it has become increasingly stringent. In the fiscal year 2021, 65% of the warning letters issued by the FDA highlighted data integrity issues, compared to 47% in 2019. Data integrity problems can lead to severe consequences, such as the denial of drug approvals, product recalls, and facility closures.

The FDA is committed to enforcing rules and regulations to ensure the safety and effectiveness of the intellectual property being researched. In this article, Rod McGlashing, a Data Science Subject Matter Expert at Medrio, explains that the presence of FDA scrutiny, or even the threat of it, compels companies to comply with regulations, resulting in better data quality and the establishment of optimal applications for intellectual property both during and after the study.