Two Clinical Investigators Receive FDA Warning Letters

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

By signing up for a tour of the Thompson FDA Compliance Expert Suite, you are also registering to receive email offers and product updates from us. Simply click unsubscribe at the bottom of any email if you would like to discontinue delivery.

Warning Letter Alleges Investigator Overdosed Two Pediatric Subjects

Second Investigator Receives Letter over Informed Consent

J.W. Schomisch

July 11, 2025 at 12:08 PM EST

The FDA’s Center for Drug Evaluation and Research sent a Warning Letter to a Florida clinical investigator alleging he did not follow the protocol in dosing two children with the investigational drug. The June 18 Warning Letter to Peter Michael, MD with the G+C Research Group in Hialeah, Fla., was the result of a Bioresearch Monitoring Program inspection between June 3 and 11... Read More

My Research Folders

You are not Logged in yet, Please login to see Your research folders.

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

Warning Letter Alleges Investigator Overdosed Two Pediatric Subjects

My Research Folders

THOMPSON FDA

COMPLIANCE EXPERT

RESOURCES

HELP

CONTACT