A new report by the Congressional Research Service (CRS) revives the question of U.S. FDA regulation of lab-developed tests (LDTs). However, attorney Jeffrey Shapiro, of Washington-based Hyman Phelps & McNamara PC, told BioWorld that the agency is no longer in a position to unilaterally impose a regulatory regime on LDTs, and that there is little likelihood that any enabling legislation will pass until at least 2021.
LONDON – Three years after the implementation of new U.S. legislation requiring clinical trials to report results within 12 months of completion, more than half are not published on time and compliance is not improving.
Novo Nordisk A/S' Ozempic, a once-weekly injectable version of the company's glucagon-like peptide-1 (GLP-1) receptor agonist, semaglutide, first FDA-approved in late 2017, has won the agency' approval for a new indication: reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D) and known heart disease.
PERTH, Australia – Australia’s Parliament has passed the first tranche of medical device regulations reforms that follow a number of consultations over the last two years.
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