All news articles for January 2013

Lonza may move away from manufacturing

Lonza hints at manufacturing cuts

By Dan Stanton

Lonza says it will “move from a product-oriented to a market-oriented organisation” suggesting a restructuring of its manufacturing division is on the cards.

Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs

Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs

By Zachary Brennan

The Association of Clinical Research Organizations (ACRO) and others are cautioning the FDA against issuing guidance that could muddle or duplicate the responsibilities of institutional review boards (IRBs) and trial sponsors or CROs.

US seeks exemption from new EU API import laws

update

US asks for exemption from EU API import laws

By Gareth Macdonald

The US wants exemption from new European Union import rules for active pharmaceutical ingredients (APIs) and says such status would cut manufacturers' admin and help prevent drug shortages.