Tag Archives: FDA

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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A Blueprint for FDA Reform

By Jennifer Ringler | Published: April 26, 2011
The FDA five-year strategy emphasizes a more coordinated—and skeptical—response to globalization of the drug supply chain. On balance, the strategy continues to focus more on managing risk than assessing benefit—industry take heed. Earlier this month, FDA released a five-year, forward-looking strategic priorities report—“Responding to the Public Health Challenges of the 21st Century”—that outlines what the industry [...]
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Governor Howard Dean: Financing the Future of US Drug Innovation

By William Looney | Published: April 6, 2011
Will it be More Good Pills — Or that Porsche? The Obama Administration’s signal achievement to date — passage of comprehensive health reform legislation — continues to inspire confusion and contradictions across the political spectrum. Despite its scope, the bill is dismissed by many Democrats for what it does not do, while the GOP [...]
Posted in FDA, R&D, Regulatory, healthcare | Also tagged , , , , | 1 Comment