The OCP presented its priorities for 2023 and beyond at the RAPS/AFDO Combination Products Summit on 8 November.
The US Food and Drug Administration’s Office of Combination Products has set its sights on publishing the final guidance for human factor designs for combination products, an agency official said Tuesday at the RAPS/AFDO Combination Products Summit in Columbus, OH.
The draft guidance was published in February 2015, and combination product experts have been anxiously awaiting an update since
Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.
The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.
Despite Danaher’s confident outlook, the company acknowledged near-term profitability fluctuations, particularly in the second quarter. Matt McGrew, Danaher’s CFO, clarified during the company’s first-quarter earnings call on 22 April, that expected operating margin softness in the second quarter – forecast at 25.5% – was not related to tariffs, but to seasonal dynamics in its respiratory diagnostics business.
