http://blog.pharmtech.com The blog of Pharmaceutical Technology magazine Wed, 08 Feb 2012 17:14:05 +0000 http://backend.userland.com/rss092 en This blog post was written by Lynn D. Torbeck Textbooks and journal articles treat common cause variation as if it is an inevitable fact of nature and beyond our control: "In any production process, regardless of how well-designed or carefully maintained it is, a certain amount of inherent or natural variability ... http://blog.pharmtech.com/2012/02/08/where-is-variability-coming-from-and-what-have-we-done-to-minimize-it/ 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. http://blog.pharmtech.com/2012/02/07/pfizers-birth-control-recall/ Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency's case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. In addition to offering her support for ... http://blog.pharmtech.com/2012/02/06/is-the-us-facing-a-pharmaceutical-manufacturing-gap/ 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. In terms of background, the BPCI Act was passed in March 2010 as part of Affordable Care Act, and it creates an abbreviated licensure pathway for ... http://blog.pharmtech.com/2012/02/03/fda-gives-biosimilars-update/ Rumors of change at AstraZeneca have been rumbling through newspapers all week and yesterday the company finally revealed the details by releasing a statement about its  restructuring initiatives "to drive productivity and support innovation”. It all sounds very high and important but basically it boils down to job cuts. And ... http://blog.pharmtech.com/2012/02/03/astrazeneca-axe-hovers-above-7300-workers/ 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. This knowledge can lead to fewer nonconformances and less rejection and rework, according to several International Conference on Harmonization (ICH) Q11 expert ... http://blog.pharmtech.com/2012/02/02/fda-on-the-relationship-between-manufacturing-and-regulatory-flexibility/ As part of Ranbaxy’s recently announced consent decree, the company is required to set up a program whereby whistleblowers can come forward with information related to potential violations of the Food, Drug, and  Cosmetic Act. According to the decree, available through Pharmalot’s post, Ranbaxy must, within 75 days, establish a ... http://blog.pharmtech.com/2012/02/02/fda-encourages-whistleblowers-just-not-its-own/ written by Janet Woodcock, MD, Director for FDA’s Center for Drug Evaluation and Research 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 year, FDA ... http://blog.pharmtech.com/2012/01/31/how-science-and-strategic-collaboration-led-to-a-new-%e2%80%9cpersonalized%e2%80%9d-cystic-fibrosis-treatment-for-some-patients/ Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry. Several pharmaceutical majors continue to invest in this emerging field as evident by Roche's $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related ... http://blog.pharmtech.com/2012/01/30/roche-makes-bid-to-advance-position-in-personalized-medicine/ Pharmaceutical drug development is becoming more and more expensive, with a high incidence of products failing late-stage trials. Governments and healthcare payers are demanding medicines that offer a balance of benefit and cost. Could personalized medicines and diagnostics offer a solution to both? In April 2011, the EMA’s Committee for Medicinal ... http://blog.pharmtech.com/2012/01/27/personalising-for-better-products/