Tag Archives: Regulatory

Government-Funded Research: Is It That Different?

By Guest Blogger | Published: February 2, 2012
In December 2011, the President’s Bioethics Commission released its “Moral Science: Protecting Participants in Human Subjects Research.” The report was ordered by President Obama following an October 2010 revelation that the US Public Health Service supported unethical research in Guatemala from 1946 to 1948 that involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases [...]
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Compliance Top Driver of Change, Survey Says

By Ben Comer | Published: October 17, 2011
Last year, only two percent of the respondents surveyed by Cegedim cited regulatory and compliance issues as a driver of new technology adoption, and six percent said regulatory and compliance was a primary driver of pharmaceutical business model or process change. A lot can happen in a year.
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So, Where Are We with ACOs?

By Guest Blogger | Published: July 13, 2011
Tom Norton gets to grips with what an Accountable Care Organization is … and what it is not. Sixteen months into the new Healthcare Reform law, many continue to wonder about the status one of the most confused aspects of the new HCR — the elusive Accountable Care Organization, or ACO. And why are ACOs viewed [...]
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Bad Ad: One Year of Fear

By Ben Comer | Published: June 13, 2011
FDA’s Bad Ad program, launched in May of 2010, resulted in some 328 reports of potentially untruthful or misleading promotion, a handful of Warning Letters, and several Untitled Letters. But the single most effective tool in the Bad Ad program’s toolkit, according to Arnie Friede, principal at Arnold I. Friede & Associates, and a former associate [...]
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Indian Government Proposes Ban on Physician Gifts

By Ben Comer | Published: June 6, 2011
India’s Department of Pharmaceuticals released a 14-page “voluntary code” for drug marketers, which includes a strict ban on gifts to prescribers, among other things. The code, which is open for public comment until June 30th, states that “no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe” [...]
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