Boston Scientific Elects Dr. Jessica L. Mega and Susan E. Morano to Board of Directors
“We are pleased to expand our board of directors with two highly qualified executives from different sectors of the healthcare industry.”
FDA Releases Final Guidance on Premarket Submissions for Device Software Functions
“Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. The agency is hosting a webinar for industry on July 20 to provide an overview and answer questions about the new final guidance.
FDA Announces Additional Steps to Modernize Clinical Trials
The FDA is requesting feedback on three new draft guidances related to clinical trials, including how they should be applied to increasingly diverse trial types and data sources.
AAMI and BSI Partner to Publish Guidance on Artificial Intelligence
AAMI and the British Standards Institute (BSI) have jointly published new guidance documents on performing risk management for machine learning or artificial intelligence incorporating medical devices.
FDA Offers Funding for Adoption of Advanced Manufacturing Technologies
Medtech companies can receive up to $300,000 for the adoption of advanced manufacturing technologies through the MDIC Advanced Manufacturing Clearing House. The program is designed to speed adoption and provide guidance for industry and the FDA on the most beneficial applications of advanced technologies.
FDA CDRH Portal Now Offers Tracking of Pre-Submissions
The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal.
FTC Sues to Block Amgen Acquisition of Horizon Therapeutics
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.
President Biden To Nominate Monica Bertagnolli, MD, as Director of NIH
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.
FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing
“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.
FDA Issues Draft Guidance on Use of Decentralized Clinical Trials
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.
