Several things are changing in regulatory inspections in the US and industry should be prepared. Zena Kaufman, division vp of global pharmaceutical operations at Abbott, highlighted what’s new in domestic inspections at the PDA-FDA 2011 Joint Regulatory Conference taking place this week in Washington, DC. Read more »
FDA’s Monica Caphart listed the top 10 domestic inspection observations today, in Washington, DC, at the PDA-FDA Joint Regulatory Conference. Number one on the list is the quality control unit, says Caphart, who is director of the Domestic Operations Branch within FDA’s Division Office of Regulatory Affairs. Below are the other top-10 citation areas: Read more »
As I wrote last week, the market for vaccines is expanding, and the newswires have stories about these products almost daily. Sanofi and GlaxoSmithKline, to name just two major players, are increasing investments in research and manufacturing capacity for these therapies. Kalorama Information predicts that sales of pediatric vaccines will grow even more quickly than sales for adult vaccines. Yet drugmakers have surely noticed that not all publicity about vaccines has been positive. Read more »
As blogged earlier this week, the Senate Healthcare, Education, Labor, and Pensions committee met this week to discuss the pharma supply chain and Senator Barbara Mikulski (D-MD) had some interesting comments about making supply chain concerns a national security issue. Below are highlights from her remarks, including a Q&A portion with FDA’s Deborah Autor, as sent to PharmTech by the Senator’s press office.
Every now and then, media headlines become excited by a new potential ‘cure’ for cancer. Usually, this excitement stems from the results of very early research, which often involves a vegetable. Tomatoes, broccoli, cabbage, sprouts and beetroot have all had their turn in the spotlight over the years. Read more »
At a time when the headlines have been screaming about the inability of the two political parties to compromise on issues of taxation and government spending, I was gratified to read that the US legislative bodies are, in fact, still capable of passing legislation. The America Invents Act, the first comprehensive reform of patent law in 60 years, was passed by the Senate by a vote of 89-9, on September 8, 2011. The bill has been sent to President Obama, who is expected to sign it into law on September 16, 2011. Read more »
Written by Karen Ginsbury
With the finalization of FDA’s Guidance [i] in January of this year, the process validation paradigm has undergone an irreversible change. Out with the old “three batches and a prayer and we’re done for the next 25 years” and in with the life-cycle concept of validation management. Read more »
Today, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy Deborah Autor testified before the US Senate HELP committee regarding the pharmaceutical supply chain and related security issues. She asked for additional FDA authority in several key areas. Read more »
The other day I was editing an interesting piece about e-prescribing in Europe. A lot of processes in both healthcare and the pharma industry, as well as in every other aspect of our lives, are moving to electronic systems and, of course, such systems offer many benefits. Being sceptical, however, I turned to my colleague and asked, “what happens when the system goes wrong?” Because, let’s face it, all electronic systems seem to suffer serious issues at some point. Read more »
The patent cliff is beginning to reduce Big Pharma’s sales figures as generic versions of branded drugs enter the market. Although FDA has remarked that pharmaceutical innovation is beginning to increase, not all companies are going to be able to market enough new drugs to make up for lost sales. So how will these vulnerable companies maintain their profits? Read more »
From PharmTech.com