The FDA will hold a public meeting on March 20 to discuss the use of complex innovative designs (CID) in clinical trials of drugs and biological products to inform regulatory decision making. The meeting is intended to help the FDA develop a guidance document on CID, as required by the 21st Century Cures Act, and develop a CID pilot program. To register for this meeting, visit: https://complexinnovativedesigns.eventbrite.com/ (Regulatory Focus)
IBM Watson, CDC hunting for new blockchain applications for healthcare
The Centers for Disease Control and Prevention (CDCP) has signed on with IBM Watson Health to explore new applications for blockchain in healthcare. IBM says this is an expansion of its existing work with the U.S. FDA, which is exploring potential blockchain applications for EHRs, clinical trials, internet-of-things, genomics and more. Blockchain technology offers a high level of security, and when combined with AI holds big promise for managing patient data. (HealthcareITNews)
FDA considers setting up a new “Office of Patient Affairs”
As part of its efforts to capture patients’ perspectives, the U.S. FDA is considering establishing an “Office of Patient Affairs” that would be tasked with coordinating patient engagement across the agency. The move to create the office would be part of the agency’s efforts to offer a single entry point to the Agency for the patient community and patient stakeholders. (Regulatory Focus)
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Welcome freelance writer Madison Arenchild!
Madison Arenchild, who relocated to San Diego in October 2016, is a freelance writer for Clinical Research Currents. Madison graduated from UCLA in the department of The Institute for Society and Genetics in 2016, where she studied developmental biology and public health. She also works in digital marketing, and spends her time Read more