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DTC Marketing & Regulatory/Legal

Your biggest ally in implemention of social media programs? Legal & Regulatory teams

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“Keep your friends close but your enemies closer” is a classic line from my favorite movie of all time “The Godfather” and is a great approach in trying to work with medical, legal and regulatory teams in a changing marketing environment. Read More...
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The regulatory and approval environment gets stormy

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The only constant thing in the universe is change. That could be the motto for the drug companies as Peggy Hamburg assumes the controls of an agency that has come under a ton of criticism. First we learned that the person responsible for medical devices resigned as there have been questions from Chuck Grassley about devices that were approved over the objections of scientists and doctors within the FDA, as well as allegations from within the agency of similar issues. Then we hear that Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, is under investigation for an alleged conflict of interest. Ms Hamburg is also promising faster enforcement action and bigger fines for companies that cross the line. What will most drug companies do now? My guess is that they will keep a low profile until the new captain of the FDA gets the crew in shape and plots a course to get the FDA back on track. Read More...
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