The US Food and Drug Administration (FDA) has alerted the media to
the preliminary findings of its inspection of the Chinese facility
that supplied the active pharmaceutical ingredient (API) for
Baxter's heparin - now recalled...
The Biotechnology Industry Organization (BIO) urged the World
Health Organization (WHO) to change its International
Nonproprietary Names (INN) policy for biological products at a
meeting last week in Geneva.
As the US Food and Drug Administration continues its deliberations
on generic biopharmaceuticals, the industry body representing
generic drug manufacturers has said that the time has now come for
the agency to make some hard decisions,...