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Three plastic syringe makers have received FDA warning letters describing violations related to the sale and distribution of plastic syringes made in China that have not been cleared or approved for sale or distribution in the U.S. Read More
Devicemakers considering how to comply with the recently released Quality Management System Regulation (QMSR) will need to keep on hand a copy of the international standard ISO 13485 — the copyright-protected document that’s included only by reference in the new regulation. Read More
AstraZeneca has strengthened its oncology and rare disease portfolios with two buy-outs totaling close to $3.5 billion, the company has reported. Read More
Within the supply chain universe, medical technology and its countless components needs to stay front and center when competing with other industries, emphasized the FDA’s lead officer on the subject during a two-day workshop on generic drug-device combination products last week. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Four units within the FDA have worked together to publish a paper to provide greater transparency on how they will collaborate with the pharmaceutical industry as it develops and deploys AI technologies. Read More