Dr. Scott Gottlieb, FDA Commissioner of Food and Drugs

FDA’s Gottlieb Promises Agency Will Help Speed Clinical Trials

It’s not going to be business as usual at the U.S. Food and Drug Administration (FDA) going forward, new Commissioner Scott Gottlieb told attendees of the RAPS (Regulatory Affairs Professionals Society) 2017 Regulatory Convergence conference on September 11. There are many areas where the agency wants to increase its activity, Gottlieb said. For example, the […]

Halle Showalter Salas, Senior Internal Consultant for Employer Market Strategy, Premera Blue Cross

Focus on Patient-Centric Informed Consent Yields Dividends

Long-time pediatric trial professional Halle Showalter Salas is “firmly convinced” that patient-centric informed consent improves compliance and retention throughout a clinical trial. She spent more than seven years as a research and family liaison and vice chair of the institutional review board at Seattle Children’s Hospital. Currently, she’s senior internal consultant for employer market strategy […]

NJ Gov. Chris Christie: “This rule will help us address any concerns about whether treatment decisions of prescribers are being improperly influenced.”

Proposed New Jersey Rule Could Have Chilling Effect on Clinical Trials

A proposed new rule could have a chilling impact on clinical trial research in the state of New Jersey. It’s no stretch to imagine similar bills cropping up in other states. The rule would set a $10,000 cap on the amount a prescriber can accept from manufacturers in a calendar year for bona fide services. […]

Nicholas Focil, Managing Director, FOMAT Medical Research

Understanding Cultural Nuances Key to Successful Hispanic-American Patient Recruitment

As the largest, and fastest growing, minority population in the United States, Hispanic-Americans represent a burgeoning patient pool, says Nicholas Focil, managing director of FOMAT Medical Research. However, “that population is often overlooked,” Focil says. Part of the problem, he suggests, is that many American healthcare providers, particularly Caucasians, aren’t familiar with cultural nuances among […]