Tag Archives: DIA

Industry and FDA Brace for Change

While the convention floor of the 46th annual meeting of the Drug Information Association bustled with the usual vendors touting the latest and greatest clinical trial technology, the panels (particularly those that featured FDA members) had a remarkably somber tone. The main refrain was: “Things are going to change and everyone must step up or […]
Posted in Regulatory, Strategy | Also tagged , , , , , | 1 Comment

Hamburg Delivers DIA Keynote

FDA Commissioner Margaret Hamburg delivered this year’s keynote speech in front of a packed room of pharma and bioscience personnel at the 46th annual meeting of the Drug Information Association, which opened Monday morning. Hamburg started her speech by explaining how her earliest goal as FDA chief was to build the field of regulatory science—an […]
Posted in Events, FDA | Also tagged , , | 2 Comments

Building a Better Brief Summary

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 […]
Posted in Advertising, Regulatory | Also tagged , , , , | 4 Comments

Live from DIA: Bridging the Data Gap

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 […]
Posted in Technology | Also tagged , , , | Leave a comment

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

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 […]
Posted in Advertising, Regulatory | Also tagged , , , , , | 2 Comments
  • Categories

  • Meta