Angie Drakulich

Here at ExcipientFest 2012, in connection with IPEC, rooms are full of attendees listening for ways to better follow GMPs, for best testing practices.

Here at ExcipientFest 2012 in San Juan, excipient manufacturers and users are debating how to move foward surrounding the issue of atypical visible particles found in excipients.

Today in San Juan, at ExcipientFest 2012 in partnership with IPEC, Michael Beatrice of Abbott spoke about the seven deadly sins of quality management.

This month, CDER added a new program in drug safety to its "CDER World" platform for regulatory training and education.

FDA’s Center for Drug Evaluation and Research (CDER) has been running an educational regulatory-based forum since 2005 to engage its international regulatory counterparts.

Johnson & Johnson announced this week that Sheri S. McCoy, vice-chairman of the Executive Committee, has resigned from the company. She was considered to be in line for the CEO position.

The industry is increasingly adopting continuous processing models as it works to gain better process understanding and control, an approach that is being encouraged by regulators under the QbD paradigm.

Provisions in the Affordable Care Act (ACA) drove out-of-pocket costs down, while increasing drug spending among 19 to 25-year-olds in 2011.

The National Institute for Bioprocessing Research and Training in Ireland and Waters are partnering on training and research to increase large-molecule characterization capacity and knowledge.

“One of the most daunting challenges facing pharmaceutical companies is securing the long and complex supply chains that are typical in today’s global industry.

Is it a mark of desperation? UK-based pharma company AstraZeneca has resorted to suing the US Food and Drug Administration in a bid to stop it from approving generic competition to Seroquel, the company’s blockbuster anti-depressant, before December 2012.

FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are approximately 50 such guidances planned.

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.

Genotoxic impurities and how to identify them and control for them have been a concern for several years in the pharmaceutical manufacturing industry. Pharmaceutical Technology spoke with Bo Shen, PhD, principal scientist at Amgen and chair of the AAPS Pharmaceutical Trace Impurities Focus Group, to gain insight on key challenges.

Has the long-awaited guidance answered all of the industry's questions?

FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.

Pfizer has proactively recalled 28 lots of birth control pills. An investigation by the company discovered that some blister packs may have mixed up the inert and active ingredient tablets. Watch the PharmaFaceoff video blog on YouTube to see what happened and why.

Rachel Sherman, MD, Associate Director for Medical Policy, within FDA’s Center for Drug Evaluation and Research, gave a press briefing today. Below is a summary.

Pharma announces plans for the year ahead at annual JPMorgan Global Healthcare conference.

FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.

Quality-by-design or “enhanced” approaches to drug manufacturing offer several benefits to industry, including better process understanding and better understanding of the interrelationship of material attributes and process parameters.

Targeting a drug for small subgroups of patients is a new way to find effective therapies. This is often called personalized medicine, and it’s one of today’s most promising areas of new drug development.

Last night, President Obama issued a call to action for manufacturers that involves reducing outsourcing. His 2012 State of the Union address provided a blueprint for rebuilding America’s economy-and a large component is of that plan is to bring manufacturing back to the US.

Ever wish you were a fly on the wall in another laboratory? Well, a new journal website offers the industry opportunities to do just that-to see through video how other scientists carry out particular experiments and processes.

2012 will be a transition year for pharma, one of the most important in the industry’s history of product cycles that spin from plenty to penury. On the positive side, the fires of drug discovery are finally being stoked by a growing understanding of how genomics shape the biology of disease.

The benefits of harmonization may be on industry's wish list, but buying into change is another story.

As part of the BRIC bloc with Russia, India, and China, Brazil is one of the world's leading emerging economies and is also considered by IMS Health to be one of seven pharmerging nations, which also include Mexico, Turkey, and South Korea.

Cultivating a productive investment environment will require partnerships with a range of stakeholders.

Novartis AG and Novartis Pharmaceuticals Corporation have been focusing research efforts on rare diseases since the company was established in 1996.

AAPS Global Health Focus Group's Kishor M. Wasan discusses new initiatives.