https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m3r2-nonclinical-safety-studies-conduct-human-clinical-trials-and-marketing-authorization
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)
safety studiesnonclinicalconducthuman
https://www.chrn.co/
chiron is pioneering advanced in-vitro technologies, enabling pharmaceutical innovators to derive actionable clinical insights before conducting preclinical...
chirondeliveringpredictivehumanrelevant
https://www.clinicaltrialsarena.com/news/protaryx-medical-completes-first-in-human-trial-of-transseptal-puncture-device/
US-based device company Protaryx Medical has completed a first-in-human trial of its transseptal puncture (TSP) technology.
human trialmedicalcompletesfirstpuncture
https://www.tga.gov.au/resources/publication/meeting-statements/human-research-ethics-committee-and-tga-clinical-trials-discussion-forum-communique-meeting-3-13-august-2025
Communique from the 3rd meeting of the Human Research Ethics Committee and TGA Clinical Trials Discussion Forum, 13 August 2025
human research ethicsclinical trialsdiscussion forumcommitteetga
https://www.kristv.com/health/fda-approves-first-human-clinical-trials-for-gene-edited-pig-kidney-transplants
Scientists reached a major milestone in animal-to-human transplant research as the FDA approved the first human clinical trials for kidney transplants from...
human clinical trialsfdafirstgeneedited
https://www.legislation.gov.uk/uksi/2006/2984/contents/made
These Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (the Clinical Trials Regulations) which implement Directive 2001/20/EC...
human useclinical trialsmedicinesamendment
https://www.biospace.com/scitech-development-announces-irb-approval-for-human-clinical-trials
SciTech Development, a clinical-stage pharmaceutical company with a novel and patented drug delivery platform, announced that the company has received IRB...
human clinical trialsscitechdevelopmentannouncesirb