FDA Keeping Eye on Online Drug, Device Benefit Promises

The U.S. Food and Drug Administration (FDA) understands you can’t control absolutely everything posted about your drug or device as part of your effort to solicit new clinical trial subjects, but you’d better keep an eye on promises made regarding how much your product can benefit people. That’s the warning from Mitchell Parish, JD, RAC, […]

FDA: Risk-Based Monitoring Remains Fuzzy Concept in Clinical Trials Industry

Risk-based monitoring (RBM) has become a confusing buzzword that too often means different things to different people. That’s a potentially dangerous situation, says David Burrow, acting deputy director of the Office of Compliance for the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER). “RBM should be one part of a larger […]

Is Generation Gap Slowing mHealth Adoption in Clinical Research?

Generation Xers and Millennials look at technology differently, says Jeri Burr, a program director at the University of Utah. “These generational differences affect everyone,” she notes. Take a look at mHealth adoption in the clinical trial industry. While hesitant to lay too much blame on a tech generation gap, mHealth proponent Noel Chandler, CEO of […]

Former FDA Auditor: PIs Primary Target When Agency Comes Calling

Principal Investigators (PIs) need to surround themselves with a good team when a Food and Drug Administration (FDA) inspector comes calling, but they risk serious problems if they forget the buck stops with them. That’s the warning from former auditor that prepared sites for FDA inspections, Chavon Steele, now a senior clinical trial monitor for […]