Tag Archives: FDA

Off-Label Comments Online: Keep Doing What You're Doing, Says FDA

By Ben Comer | Published: January 3, 2012
Those in favor of a less is more approach to FDA social media guidelines got what they wanted for the holidays: a trim, 15-page document on how to respond to unsolicited off-label comments
Posted in Advertising, E-Media, FDA, Legal, Marketing, Regulatory, Technology, compliance, social media | Tagged | Leave a comment

Accelerated Approvals Could Raise Risks for Patients

By Guest Blogger | Published: November 10, 2011
By Erik Greb. FDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s lower [...]
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FDA Finding Fuels Indian Crackdown on Sub-standard Drugs

By Guest Blogger | Published: July 27, 2011
By Mangesh Sai, Asia Correspondent. A routine monthly inspection carried out by the Food and Drugs Administration (FDA) authorities in the state of Maharashtra, India, last month noted an increase in the number of sub-standard drug samples raising apprehensions about the availability of safe and genuine drugs in the state. Officials pointed out that 26 drug samples [...]
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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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CDER Addresses 'Challenges of Globalization' With a New Office

By Ben Comer | Published: June 8, 2011
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, Integrity [...]
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