The agency offers a glimpse of its regulatory agenda, although several have been carried over through multiple list updates.
Complex generic drug sponsors now can track the US Food and Drug Administration's plans for new and revised product-specific guidances and potentially avoid development or application assessment setbacks.
However, like the agency’s other guidance agendas, in many cases product-specific guidances (PSGs) have remained listed as upcoming or due...
Arizona’s governor Katie Hobbs pointed to Trump’s One Big Beautiful Bill and other federal failures as she signed an executive order to increase access to medications in her state.
Viatris and Amphastar are expanding their complex generic portfolios with the planned launches of FDA-approved versions of Vifor Pharma/Daiichi Sankyo’s Venofer (iron sucrose). The FDA’s database also show Sandoz holds an approval for generic Venofer, though it has not disclosed launch plans.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
