Nycomed wants to duplicate the success of rival PE Corp. by expanding its role as a supplier of knowledge-oriented products. It already has a play in gene-based drug discovery including a high-throughput gene sequencing system and SNP analysis technologies.
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US regulators are proposing updates to a guidance document they finalized in February for devices used to clear arteries of plaque. The updated language specifically addresses software interoperability, pyrogenicity and certain performance-testing requirements.
US House Panel Votes For 5.8% Cut In FDA Device Center’s 2021 Budget Authority, Seeks COVID-19 Review
While the House Appropriations Committee is calling for a 5.8% cut in the FDA device center’s budget authority, it nevertheless gives a boost to the agency’s medical device safety and cybersecurity functions.
The former FDAer who wrote the Quality System Regulation in the 1990s says the US agency should change the name of the rule, which has been undergoing a revision since 2018 to be harmonized with international quality systems standard ISO 13485. A name change would help delineate the retooled reg from its GMP predecessors, said Trautman, who also shared a few other thoughts about the agency’s ongoing QSR redo.