Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
The FTC argues that the $27.8 billion transaction would enable Amgen to use rebates on its existing blockbuster drugs to stifle competition for Horizon’s two monopoly products for thyroid eye disease and chronic refractory gout.
Dr. Bertagnolli is a surgical oncologist, cancer researcher, educator, and current director of the National Cancer Institute (NCI). She previously served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute.
“Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products” and “Artificial Intelligence in Drug Manufacturing” were developed to support the use of AI/ML while addressing concerns related to security, bias and risk, and spur feedback and discussion from stakeholders.
The draft guidance covers DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs for drugs, biological products, and devices. The comment period is open until August 1, 2023.
There are several tactical approaches to design that can help medtech manufacturers inspire patient confidence in their products and ensure proper usage. Following are three ways you can help ease the burden of delivering and receiving quality care through product design.
At the 2023 MedCon Conference in April, Michael Maier, VP of Strategic Regulatory and Quality at Veranex, and James Pink, Director of Medical at Element, provided updates on medical device regulation in Switzerland and the UK.
The voluntary program is designed to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
In spite of continuing delays to implementation deadlines for EU MDR/IVDR, post-market surveillance requirements are currently in force. Hence, manufacturers need to urgently establish a PMS system to identify potential nonconformances and safeguard users and patients.
