n a recent Clinical Leader Live! episode hosted by Life Science Leader Chief Editor Ben Comer, clinical trial experts Mitchell Katz, SVP, global clinical operations at Kyowa Kirin; Jessica Powell, VP, clinical operations at Alto Neuroscience; and Michael Krams, chief quantitative medicine officer at Exscientia,...
Sponsors can employ several postmarketing strategies to beef up safety and efficacy data on populations that were under-represented in initial clinical trials of drugs and biologics, according to new draft guidance issued by the US Food and Drug Administration (FDA)....
In their combined feedback to the FDA, ACRP members and volunteers weighed in on a variety of concerns they had over vague language and possible misconceptions about DCTs in the draft guidance....
Following the release of some initial reactions to the draft guidance in May, volunteer members of ACRP’s DCT Think Tank Regulatory Working Group and other subject matter experts, including the ACRP Content Committee and ACRP Fellows, took a closer look at how FDA worded its...
The agency proposes significant revisions to oversight programs for drugs and medical products....
The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer's disease....
The U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders....
Investigators will be assessing the use of the drug to treat impaired social motivation, or asociality, which is a symptom of schizophrenia that can cause significant functional impairment....
The U.S. Food and Drug Administration is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites....
The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year....
