FDA Meets With Clinical Decision Support Firms To Address Challenging Cases
This article was originally published in The Gray Sheet
Executive Summary
The agency recently sat down with members of the Clinical Decision Support Coalition who presented mock case studies of regulatory submissions for software supporting drug therapy decisions. The coalition hopes to get feedback on how FDA intends to regulate such software in the coming months.
You may also be interested in...
CDRH Guidance Priorities Include Lab-Developed Tests, Adverse Event Reporting, Third-Party 510(k) Review
FDA's device center issued its annual “A List” and “B List” guidance priorities for fiscal year 2016, spotlighting efforts to address Unique Device Identification direct marking, Medical Device Reporting rules, laboratory-developed tests, 510(k) third-party review, companion diagnostics, and more.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.
Could Eledon’s Anti-CD40L Change Transplant Medicine?
Eledon Pharmaceuticals’ CD40 Ligand blocker has yielded impressive results for post-transplant immunosuppression and cutting-edge transplant doctors have also used it for pig-to-human kidney and heart transplants, opening up the field of xenotransplantation.