Outsourcing

Grace McNally, in the Office of Compliance at FDA's CDER, discusses the role of QbD and pharmaceutical quality systems as it relates to contract manufacturing.

Team leaders in FDA's Office of Generic Drugs provide an overview.

Plus, novel dosage forms and emerging trends.

From healthcare to corruption to life expectancy, here's what we can learn from the past decade.

Directors and staff miss the mark when it comes to following procedures.

It's customary among columnists to begin a new year with some predictions about what's to come. We don't honour that custom every year, but with what the contract services industry went through in 2009, it seemed appropriate to share thoughts on what we expect for 2010.

BioNanomatrix (Philadelphia) names Edward Erickson president and CEO; and More.

Merck & Co. Acquires Avecia Biologics; Ambrilia Biopharma Closes Manufacturing Facility; And More.

Also, Abbott to acquire Starlims Technologies; GSK Biologicals to form alliance with Intercell.

Company and People Notes: Also, Pfizer and Protalix enter agreement; Watson acquires Arrow Group; and more.

Also, Merck & Co. extends collaboration with Idera Pharmaceuticals; Pfizer establishes R&D center in China; more...

Particularly in a more connected world, individual contributions can make a difference.

Dumbed-down presentations and poor speaker selections are destroying a valuable industry tool.

With so many healthcare and pharmacy websites, consumers could use the agency's nod of support.

Why is the correct storage of stem cells so important for the future of medical innovation?

Big Pharma's efforts to reduce working capital will hurt CMOs for years to come.

The end of 2009 is creeping closer and analysts are already looking towards 2010 and wondering what new challenges are in store for the pharma industry.

Company and People Notes: Merck KGaA to build R&D hub in Beijing; Depomed appoints VP of operations; more...

View Jim Miller's presentation from the AAPS 2009 Meeting and Exhibition.

Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more...

Company and People Notes: 3M forms agreement with VaxInnate; TRIN Pharma appoints CEO; More...

Lonza (Basel, Switzerland), the large contract manufacturer of small-molecule and biologic-based active pharmaceutical ingredients (APIs), announced last week a series of cost-cutting measures for the next 12 to 18 months.

Company and People Notes: sanofi aventis forms pact with Micromet; Laureate Pharma adds members to its business team.

A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.

Contract organizations waiting for the pipeline to come roaring back are kidding themselves.