Guest Column: 4 Tips For Speeding Device Reviews, Even Without An 'Expedited' Pathway
This article was originally published in The Gray Sheet
FDA's new Expedited Access Program offers an accelerated pathway for select devices and diagnostics, but companies can help speed the regulatory process even for products that don't qualify for the program by following certain strategies, explains David Novotny, with Novella Clinical.
You may also be interested in...
Siemens Healthineers' product mix of diagnostics and imaging products meant it was in the middle of a very dynamic situation when COVID-19 struck.
The WHO’s new "living guideline" against remdesivir’s use in hospitalized patients notwithstanding, some key opinion leaders in India see a role for the antiviral, but underscore that COVID-19 is still in its infancy and all repurposed therapies for the disease still have a long way to go. They also see the US remdesivir studies as more robust.
Join us for a brief audio tour around the past week's major global biopharma industry developments, in this podcast version of Scrip's Five Must-Know Things.