Ther Innov Regul Sci
March 2025
The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 signed on May 30, 2018 under President Trump has been championed by patient advocacy groups as a victory for individuals with life threatening illnesses willing to undergo experimental treatment. The act is not a novel idea, but rather a nuanced result of the previous attempts to challenge the US Food and Drug Administration's (FDA) authority on drug approval and distribution. Currently, right-to-try programs coexist with an already existing expanded access program run by the FDA.
View Article and Find Full Text PDFIn 2016, an unprecedented Pseudo-nitzschia australis bloom in the Gulf of Maine led to the first shellfishery closures due to domoic acid in the region's history. In this paper, potential introduction routes of are explored through observations, a hydrodynamic model, and a Lagrangian particle tracking model. Based on particle tracking experiments, the most likely source of to the Gulf of Maine was the Scotian Shelf.
View Article and Find Full Text PDFWorldwide, warming ocean temperatures have contributed to extreme harmful algal bloom events and shifts in phytoplankton species composition. In 2016 in the Gulf of Maine (GOM), an unprecedented bloom led to the first domoic-acid induced shellfishery closures in the region. Potential links between climate change, warming temperatures, and the GOM assemblage, however, remain unexplored.
View Article and Find Full Text PDF