Exploring the US FDA's Upcoming Complex Generic Product-Specific Guidance Lists
The agency offers a glimpse of its regulatory agenda, although several have been carried over through multiple list updates.
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The agency said Cipla’s ANDA met all the requirements for approval, but also that there is increased demand for the products.
US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.
US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.