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We asked 40 pharma leaders, What do you think will be the greatest benefit of FDA's Generic Drug User Fees Amendments of 2012 (GDUFA)?

It will accelerate application review times 53%
It will increase the number of foreign inspections 26%
It will increase the transparency of manufacturing sites 21%

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18 September, 2012
In this Issue
The Big Sell: Biologics in the Emerging Markets
High priced biologics may have a bright future in emerging markets, but winning access in the short term will be a hard sell, writes Thomas Baker. Read more...
The Latest Pharm Exec Global Digest
Women on pharma boards. Six paths to success in the emerging markets. The EU’s HTA network and value-based pricing. Read all about them in our latest issue of Pharm Exec Global Digest here. More...
Sanofi's Aubagio to Square Off against MS Injectables
The most obvious competitors for Sanofi’s Aubagio, the second oral multiple sclerosis (MS) drug to receive FDA approval, would appear to be Novartis’ Gilenya, and Biogen Idec’s hotly anticipated BG-12. Ben Comer reports. More...
The Increasing Power of the Patient's Voice
Patient voices are increasing in volume, along with patients' share of voice in treatment decisions. And specialized knowledge about disease and treatment is no longer the exclusive province of practicing physicians. More...
Also in this issue?
Outsourcing: The Macro View
US's CDER to Expand Office of Generic Drugs
Doctors' Words No Longer Gospel

Product Profiles
Sciformix

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.
Read more


Recruitment Profile

Dessault Systems
Business Consultant Director
Dassault Systèmes, the 3D Experience Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported.
Read more


Event Profile
Concept Heidelberg

Innovation Excellence is a unique application of lean kaizen methodologies and personal coaching. It frees up capacity for innovative research, fosters ownership and significantly enhances the output of your research and innovation teams.
Read more