The US regulatory scientists who oversee biopharmaceuticals appear to be getting the funding they asked for after politicians pass a $1.2tr (€882bn) Government spending plan for fiscal 2014.
Novartis has joined the debate regarding the international nonproprietary names (INNs) of biologics saying some companies are casting unnecessary doubt on biosimilars under a guise of pharmacovigilance.
Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.
The US FDA has finally adopted the revised ICH Q11 guidelines on drug substance manufacturing nearly six months after European regulators embraced the guidelines.
The FDA says it expects more boards to join an inter-regulatory API (active pharmaceutical ingredient) inspection programme after simplifying the sign-up process.
The US Food and Drug Administration (FDA) will soon start asking drugmakers to play a greater role in guideline development. Before that process begins in-Pharmatechnologist.com takes a look at the documents published by the agency in 2011.
Baxter Healthcare remains in murky waters in regard to its infusion
pumps after announcing yesterday it would be recalling an
additional 986 of its Colleague brand pumps.
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,...
