Monthly Archives: June 2011

Bad Ad: One Year of Fear

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 […]
Posted in Advertising, compliance, Corporate Responsibility, FDA, Legal, Marketing, Regulatory | Tagged , , , | Leave a comment

CDER Addresses 'Challenges of Globalization' With a New Office

In recognition of the difficulties presented by a rapidly expanding global drug market, FDA’s Center for Drug Evaluation and Research (CDER) has created a new office “dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain,” according to memo sent by CDER director Janet Woodcock. The new “Office of Drug Security, […]
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Creating Hope For Orphan Diseases

The Creating Hope Act of 2011, along with advancements in science and a shift in focus for Big Pharma, means that rare and pediatric orphan diseases may finally get the attention they deserve. “As a society, as we’re having this big debate around healthcare, everyone agrees that there’s a certain baseline of people that we […]
Posted in FDA, Gene therapy, healthcare, Regulatory | Tagged , , , | 1 Comment

Mining Data to Gain a Competitive Edge

When gauging influence in oncology prescribing, membership in the “club” still counts As the cancer therapeutics space grows more crowded, the task of identifying and building productive relationships with “key influencers” has become vital to a successful launch strategy.  Like everything else in oncology, performing that task is harder today. What was once an inbred […]
Posted in Agency Insight, Europe, Strategy | Tagged , | Leave a comment

Indian Government Proposes Ban on Physician Gifts

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 […]
Posted in Advertising, Emerging Markets, Global, Marketing, Medical Education, Strategy | Tagged , , , , , , | Leave a comment
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