Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Many FDA-authorized AI devices lack validation data
- Over 40% of artificial intelligence-enabled medical devices cleared by the U.S. Food and Drug Administration lack clinical validation data, according to a study published in Nature Medicine.
- Researchers urge the FDA and developers to publish more clinical validation data and prioritize prospective studies to ensure the effectiveness and safety of these devices.
FDA issues warning to Chinese labs
- The FDA sent warning letters to two Chinese labs for oversight failures and animal care violations, raising concerns about data quality and integrity, reports MedTech Dive.
- The FDA will not authorize submissions relying on data from these labs and is assessing the impact on past submissions.
California leads biopharma job openings in 2024
- California had the most biopharma job postings on BioSpace for the first eight months of the year, with 9,241 jobs, 37.7% more than Massachusetts, reports BioSpace.
- Despite leading in job postings, California’s biopharma industry faces challenges, including significant layoffs and a difficult funding environment.
U.S. House passes legislation on China-based life sciences companies
- BioPharma Dive reports that the House of Representatives passed a bill restricting federal contracts with five China-based life sciences companies, citing concerns about the U.S. pharmaceutical supply chain’s vulnerability due to perceived links with the Chinese government.
- The legislation allows for additional companies to be named and gives drugmakers five years to terminate contracts, potentially increasing costs and shifting business to U.S.-based contractors.
Pediatric rare disease priority voucher program ending
- The pediatric rare disease priority review voucher program, which incentivized drug development for rare pediatric diseases, is set to expire, raising concerns among patient advocates, reports STAT News.
- The expiration of this program could slow down the development of new treatments for rare pediatric diseases, potentially affecting patients who rely on these innovative therapies.
For more insights in life sciences, check out RSM’s industry outlook.
