The US Food and Drug Administration (FDA) finalized guidance on drug development programs for rare diseases, eliminating a section on natural history and providing additional considerations related to patient and caregiver input and pediatric populations....
A research study at UW–Madison School of Medicine and Public Health is investigating a drug that could one day prevent Alzheimer’s disease....
New clinical treatments for diseases are conceived in a laboratory, then tested on animals or through simulations, and finally studied on human beings if deemed promising enough. Moving from point to point in this cycle is rarely a straight line, and costly and time-consuming trial-and-...
Are faster drug approvals by the FDA hurting the public's overall perception of clinical research?...
Commenters on the FDA's guidance on clinical investigations and drug development programs for psychedelic drugs raised concerns about decoupling drug administration from psychotherapy support, the proposed credentials for lead safety monitors and the agency’s characterization of the abuse potential of psychedelic drugs....
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data on populations that were under-represented in initial clinical trials of drugs and biologics, according to new draft guidance issued by the US Food and Drug Administration (FDA)....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weighed in on a variety of concerns they had over vague language and possible misconceptions about DCTs in the draft guidance....
Following the release of some initial reactions to the draft guidance in May, volunteer members of ACRP’s DCT Think Tank Regulatory Working Group and other subject matter experts, including the ACRP Content Committee and ACRP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....
