Back in 2022, we wrote about U.S. Food and Drug Administration’s (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” On June...more
For several years, FDA has advanced a policy of increasing diversity in clinical trial populations. During that time, FDA issued broad policy statements, as well as guidance on improved data collection and steps sponsors...more
Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after the study’s primary completion date. In the past, some companies delayed updating a clinical...more
On October 24, President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act)....more
Making individual patient-level data available for other research presents companies with challenges, but researchers and companies can take steps to minimize the risks.
Originally published in Drug and Medical Device,...more
Forty-five years ago, a scandalous medical experiment in Alabama caused the United States to reexamine the concept of informed consent. While that scrutiny continues today, a recent case from Alabama, Looney v. Moore,...more