FDA Update on ICH E6, E8, QbD and RBM in Clinical Trials
The recent FDA workshop, “Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD)...
Adaptive Clinical Trial Design Adaptive Trial Design Addiction Psychiatry AI in Clinical Trials alcohol use disorder Alzheimer's Disease Article Clinical Operations Clinical Research Clinical Trial Design Clinical Trial Operations Clinical Trial Ops Brief Clinical Trial Quality Clinical Trials CLINOPS WATCHDOG CNS Drug Development CNS Trials Conference Coverage Decentralized Clinical Trials Digital Health Technologies dual diagnosis eClinical Tech News eClinical Technology EMA Executive Interviews FDA Enforcement FDA Guidance FDA Real-World Evidence FDA Regulation FDA Regulatory Strategy GCP Compliance GLP-1 Receptor Agonists Ketamine Therapy Oncology Trials Opinion Parkinson's Disease Platform Trials Psilocybin MDMA Psychedelic Clinical Trials PSYCH PULSE Real-World Evidence site activation Site Operations study startup Treatment-Resistant Depression
The recent FDA workshop, “Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD)...
Glaukos Corporation announced positive clinical updates for its iDose® sustained-release drug delivery platform for glaucoma and ocular hypertension. The...
Omada Health’s analysis reveals that participants in their GLP-1 Enhanced Care Track maintained weight loss 16 weeks after discontinuing...
Umoja Biopharma, a clinical-stage company developing •in vivo• cell therapies, secured $100 million in Series C funding. The round...
Bayer AG announced progress in its pharmaceutical growth strategy at the 43rd J.P. Morgan Healthcare Conference, highlighting regulatory submissions...
Context Therapeutics has dosed the first patient in a Phase 1 clinical trial for CTIM-76, a T cell engager...
Eterna Therapeutics announced positive preclinical results for its lead cell therapy product, ERNA-101, in treating ovarian cancer. The study...
Quoin Pharmaceuticals (QNRX) announced positive interim data from its ongoing pediatric Netherton Syndrome clinical study of QRX003, a topical...
Pasithea Therapeutics, a clinical-stage biotechnology company, has expanded its Phase 1 clinical trial of PAS-004, a next-generation MEK inhibitor,...
AskBio, a Bayer subsidiary, has initiated a Phase II clinical trial, REGENERATE-PD, for its Parkinson’s disease gene therapy, AB-1005...