| September 27, 2012 | ISSUE NUMBER 270 VOL 8 |
Washington Report
Budget Policies Jeopardize FDA Funding, User Fees
Even though Congress authorized both existing and new user fees for the Food and Drug Administration several months ago through the FDA Safety & Innovation Act (FDASIA), efforts to cut the federal deficit raises questions about how those fees will be collected and used in the coming year, writes Jill Wechsler
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Statistical methodologies will help you capture and use drug experience data to generate meaningful inferences from pooled and observational data. This paper focuses on one such premier methodology, meta-analysis. We illustrate the application of the traditional methods of meta-analysis and also the more recent Bayesian approach to meta-analysis in the context of RAA (renin-angiotensin-aldosterone) system blockers/antagonists.
 www.Sciformix.com/smartstudy.php |
R&D
Open Innovation in Pharma: What Does it Mean?
There's a lot of talk today about "open innovation" in business and research forums — but what exactly does it mean? How does open innovation as a concept apply to the pharma sector? Does it signal a change in the way pharma companies approach research and innovation? Roy F. Waldron reports
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Informatics-driven Quality by Design for Drug Development
The Pharmaceutical industry has been slow to adopt regulatory Quality by Design (QbD) guidelines. However, leaner times force Pharmas to optimize business practices. A QbD strategy supported by modern Informatics offers significant opportunities to lower compliance costs and improve quality while delivering better therapeutic products, faster and at lower costs. This whitepaper explores the Informatics journey and its role in driving QbD adoption within drug development.  Download now |
Europe
Monsanto's Rat Tumor Scare: A Wake-Up Call for the Pharma Industry?
The furore that burst across Brussels in late September over reported findings of tumors in rats fed with genetically modified maize may seem only tangentially related to the concerns of European pharmaceutical executives — but the significance of the debate it has generated should not be lost on anyone with an eye on the relationship between industry, health and the public at large
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Emerging Markets
The Food and Drug Bar Travels to Brazil
Earlier this month members of the US food and drug law bar met with their Brazilian counterparts for the Food and Drug Law Institute's conference US & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device & Food Law & Regulation in São Paulo. The sessions focused heavily on the state of doing business in Brazil
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 // Quintiles (Research Triangle Park, NC) named Dr. Brian J. Kelly as its new president of Payer & Provider Solutions. // Amgen (Thousand Oaks, CA) has announced the appointment of ex-Johnson & Johnson Communications Leader Ray Jordan to the new position of Senior Vice President, Corporate Affairs. // Sandra Peterson is to join Johnson & Johnson as Group Worldwide Chairman and member of the company's executive committee on 1 December.// Capsugel (Morristown, NJ) unveiled its newly expanded executive leadership team. SVP and Chief Financial Officer — John Shroyer; SVP of Marketing and Chief Marketing Officer — Erasmo Schutzer; SVP of Information Technology and Chief Information Officer — Ian Robertson; SVP of Procurement and Chief Procurement Officer — Christopher Game; SVP of Corporate Business Development and Strategy — John Cullivan; SVP and President of the newly created Dosage Form Solutions — Amit Patel; and SVP of Operations and Supply Chain — Donal Loughrey. |
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What do you think will be the greatest benefit of FDA's Generic Drug User Fees Amendments of 2012 (GDUFA)?
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