The new US-Mexico-Canada (USMCA) free-trade agreement aims to make it easier for the three countries to align on inspecting medical device manufacturing facilities by using the Medical Device Single Audit Program (MDSAP). Former US FDA official Kim Trautman explains how Mexico – which currently doesn’t accept the results of MDSAP audits – can come up-to-speed with the program.
“There are different ways that [Mexico] has available to become familiar with the MDSAP audits and program requirements for them to gain the assurances they need to understand how best they might use MDSAP in their regulatory framework.” – Kim Trautman, executive VP of health sciences, NSF International
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El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.
This week, Quidel recalled the Triage cardiac panel due to a risk of false results; Teladoc and Lifebit announced new partnerships; and, a court upheld a false advertising verdict against Natera, but struck the financial penalties.
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UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.
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