FDA Wants You!

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and CDER leaders are looking for experienced industry managers to help rebuild its staff.

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Many experienced FDA staffers are ending their careers or taking on new challenges, creating a need for “renewal and replenishment of the agency,” explains Richard Moscicki, deputy director for science operations at CDER, who is leading its executive recruitment campaign. Moscicki formerly headed clinical development at Genzyme before coming to FDA in February 2013 and hopes to attract more people with similar backgrounds to public service. While some positions may be filled by internal candidates, Moscicki is looking to bring in people with leadership and management experience that may not exist at the agency.

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MHRA’s New Corporate Plan To Prioritise Science And Research

“Our vision of success is to enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research,” stated the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom as it unveiled its 2013–2018 corporate plan on 11 April. The agency announced its aims to be a leading regulator on the world stage in supporting science and research as part of its five-year corporate plan, which was developed using responses from a public consultation launched last December. Read more »

USP Updates Heparin Sodium Monograph

In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of PharmTech.

Cooperation in Global Regulation Sees Benefits

The European Medicines Agency announced on July 30, 2012, that its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes. According to EMA, the areas of orphan drugs, pediatrics, advanced therapies, pharmacogenomics, and nanomedicines have especially benefited from the collaboration. Read more »

Deep (Clean) Discussion

Rich WhitworthOn November 20–21, I had the honour of being Chairman at the Sterile Manufacturing Dialogue in Old Windsor, England. Despite a very foggy Sunday night and concern that European speakers and delegates would be delayed (many were forced to land at Gatwick airport rather than Heathrow), a healthy turn out early on Monday morning proved the worries to be unfounded.

After I kick-started the conference with a few choice words, notably the idea that many of those present would be unlikely to let me into their kitchens, let alone their sterile manufacturing facilities, the main event began. Read more »

Prosperity through Biology

Erik Greb PharmTech editor

As the unemployment rate hovers around 9.1%, the federal government needs to find ways to create jobs. Congress is debating whether a tax break on repatriated money would prompt companies to hire more workers, as I mentioned last week. Meanwhile, the Obama administration is eyeing another potential means of stimulating job growth: investing in biological research. Read more »

Could Wild Gudgeon Be Canaries in a Coal Mine?

Erik Greb PharmTech editor

Concern about pharmaceuticals in our water supply has been in the public consciousness for a few years now. In 2009, the Environmental Protection Agency found traces of various drugs in fish caught in rivers that receive effluent from wastewater-treatment plants. The drugs were believed to come from doses that people had excreted or flushed down the toilet. In response, FDA updated its guidelines for disposing of drugs. New research, however, shows another potential source of drugs in our waterways. Read more »

BIO’s Prescriptions for FDA

Erik Greb PharmTech editorIt’s not hard to find employees at large- or small-molecule drug companies who have gripes about FDA. On and off the record, people have complained that the agency’s review process is slow and that its decisions can be erratic. Perhaps hoping to make a positive contribution to this discussion, the Biotechnology Industry Organization (BIO) made several proposals last week for improving FDA’s operations. Read more »

Is Big Pharma Stifling Innovation?

Erik Greb PharmTech editorBig Pharma has offered many explanations for its anemic pipelines. All of the easy drugs have been discovered. Patent law (or another particular form of regulation) stifles innovation. The economy is forcing us to retrench. Although these explanations may be plausible, they all lay the blame elsewhere. Could Big Pharma’s own actions be discouraging research and development (R&D)? Read more »

Bugbear Turned Booster

Erik Greb PharmTech editorPharmaceutical companies can no longer take strong growth for granted, and CEOs and shareholders are lowering their expectations about future performance. The industry’s global sales growth likely will be limited to 1.3% until 2015, according to Joe Dixon, a spokesperson for Datamonitor. Compare this anemic figure to the 7.1% growth rate that manufacturers enjoyed from 2003 to 2009, and you’ll see little reason for joy in drugville. Read more »

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