The FDA issued a warning letter to Dr. Americo F. Padilla for regulatory violations in a pediatric COVID-19 vaccine trial.
The trial involved enrolling two pediatric subjects without obtaining legally effective parental or guardian consent.
The FDA cited these actions as serious breaches of human protection guidelines and ethical standards.
Investigators must ensure parental consent for minors in clinical trials to comply with U.S. regulations.
The FDA warned of potential enforcement actions, including disqualification from conducting future clinical trials.
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