Each week we highlight five things affecting the life sciences industry. Here's the latest. FDA consolidates AI efforts The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research is merging its artificial intelligence activities under a single AI council to enhance safety and ... READ MORE >
FDA
5 things to know in life sciences: Week of July 8, 2024
Each week we highlight five things affecting the life sciences industry. Here's the latest. How will the FDA be affected by the Chevron ruling? The Supreme Court's decision to overturn the Chevron doctrine reduces judicial deference to federal agency interpretations of ambiguous statutes, ... READ MORE >
5 things to know in life sciences: Week of May 27, 2024
Each week we highlight five things affecting the life sciences industry. Here's the latest. FDA issues draft guidance on platform technology designation The Food and Drug Administration has released a draft guidance aimed at providing a framework for the designation of platform technologies, which ... READ MORE >
5 things to know in life sciences: Week of May 20, 2024
Each week we highlight five things affecting the life sciences industry. Here's the latest. New collaboration explores AI-based digital pathology Microsoft is collaborating with researchers from the University of Washington as well as Providence health network to develop a new artificial ... READ MORE >
5 things to know in life sciences: Week of May 13, 2024
Each week we highlight five things affecting the life sciences industry. Here's the latest. FDA approves new self-collection approach to cervical cancer screening According to the Washington Post, the Food and Drug Administration has approved a newly developed screening test for cervical cancer that ... READ MORE >
5 things to know in life sciences: Week of May 6, 2024
Each week we highlight five things affecting the life sciences industry. Here's the latest. Biopharma industry challenges Biosecure Act BioCentury reports that the biopharma industry is actively lobbying for changes to the Biosecure Act aiming to modify legislative measures that could impact U.S. ... READ MORE >
5 things to know in life sciences: Week of April 29, 2024
Each week we highlight five things affecting the life sciences industry. Here's the latest. FDA releases final rule on laboratory developed tests On April 29, the U.S. Food and Drug Administration issued a final rule regarding regulation of laboratory developed tests, following a proposed rule in ... READ MORE >
Key takeaways for life sciences on laboratory developed tests final rule
The U.S. Food and Drug Administration released a final rule yesterday regarding the regulation of laboratory developed tests, also known as LDTs. This final rule follows a proposed rule that was released last fall. While the final rule closely follows the proposed rule released late last year, there are ... READ MORE >
5 things to know in life sciences: Week of Feb. 26, 2024
Each week we highlight five things affecting the life sciences industry. Here's the latest. 3D bioprinting: New era in regenerative medicine Recent advancements in 3D bioprinting, including the development of functional human brain tissue and replacement tissue for treating injured cartilage, signal ... READ MORE >
5 things to know in life sciences: Week of Feb. 19, 2024
Each week we highlight five things affecting the life sciences industry. Here's the latest. FDA warns against fraudulent data in medical device premarket submissions The U.S. Food and Drug Administration is alerting medical device manufacturers about the rise in fraudulent and unreliable laboratory ... READ MORE >