Monthly Archives: June 2009

Building a Better Brief Summary

By George Koroneos | Published: June 25, 2009
Image via Wikipedia FDA wanted to find out what people really think of the risk information printed on the back of pharmaceutical advertising. Surprise, people tend to absorb far less information from the giant blocks of text printed in drab language. DDMAC social science analyst Amy O’Donoghue explained FDA’s recent study results to an audience of marketers [...]
Posted in Advertising, Regulatory | Tagged , , , , , | 4 Comments

Live from DIA: Bridging the Data Gap

By George Koroneos | Published: June 24, 2009
Image via CrunchBase At the Drug Information Association’s annual meeting, Pharm Exec got a few minutes to talk with a little software company named Microsoft’s about its work in creating integration between electronic data capture [EDC] and electronic health records [EHR], and its new Amalga technology. Electronic Data Capture Integration “I don’t think electronic data capture has evolved [...]
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Working Towards a Solution : An Interview with Oracle’s Neil de Crescenzo

By George Koroneos | Published: June 24, 2009
Just a few days shy of the one year anniversary of the launch of Oracle’s Health Sciences Global Business Unit, Neil de Crescenzo, senior vice president and general manager for the business unit sat down with Pharm Exec to talk about the future of clinical trial software and technology and the need for standards and [...]
Posted in People, Strategy, Technology | Tagged , , , , , , , , | 2 Comments

Live from DIA: FDA Warning Letters Stir More Questions Than Answers

By George Koroneos | Published: June 23, 2009
A panel of regulators from FDA’s Division of Drug Marketing, Advertising, and Communications were taken to task, this morning at the Drug Information Association’s annual meeting, for 14 warning letters levied on drug companies for not including risk information in online search ads. A Sanofi Aventis employee complained about the 14 warning letters and asked why [...]
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Hamburg Addresses Drug Regulation and FDA Challenges

By Jill Wechsler | Published: June 23, 2009
The new commissioner of the Food and Drug Administration is mapping plans for turning around an agency that has been demoralized and buffeted about in the press, and has lost the trust of the American people. “Our mission is to protect the health of the people, using the best available science, in as transparent ways [...]
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