Viatris Target Rybelsus Among New FDA Product-Specific Guidances
Agency’s Running Total Of PSGs Approaches 2,000 Landmark
The latest tranche of product-specific guidances for generic development has been published by the US FDA, following two released in March and May this year.
You may also be interested in...
With glucagon-like peptide 1 products to treat diabetes and obesity continuing to gather pace, Sandoz has expressed confidence that it is capable of bring such complex products to market using its vast array of in-house capabilities.
A batch of four dozen new and revised product-specific guidances for generic products has been published by the US Food and Drug Administration, spanning a range of routes, dosages, and therapeutic areas.
Apotex has confirmed launch of a generic version of Bristol Myers Squibb’s Abraxane, with details thin on the ground.