Ask the Experts: Monitoring

The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from GCP Questions, FDA Answers, a book from CenterWatch, a WCG company. Read More

Miami Site’s Co-Owner and Pharmacist Convicted for Faking Data

The co-owner and pharmacist of AMB Research Center, a Miami, Fla., site, have both been convicted by a jury over a plot to falsify and fabricate clinical trial data for profit, the Department of Justice (DOJ) announced. Read More

Drug & Device Pipeline News

This week’s Pipeline features the first phase 3 trial approval for sarcopenia, a phase 1 trial start for neurological and neuropsychiatric conditions, and an FDA approval for a device to treat chronic limb-threatening ischemia. Read More