New developments and strategies for success in dealing with FDA, OIG, SEC, EMEA, and more.
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August 1, 2011
By:
David Ryan, Danielle Pelot
When faced with legislative scrutiny, be prepared, be truthful, and don't be afraid to say 'I don't know'...
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November 1, 2007
By:
Walter Armstrong
Approvable letters delay NDAs, cost pharma plenty, and are at an all-time high. Industry says FDA is gun-shy; the agency says it's business as usual. Who's right?
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October 1, 2007
By:
Sarah Houlton
A landmark court case in the United Kingdom has left Alzheimer's patients with mild to moderate disease unable to receive any of the three drugs that might help them—Aricept (donepezil), Reminyl (galantamine), and Exelon (rivastigmine). Eisai and Pfizer, which make and market Aricept, had challenged the ruling made last year by the National Institute for Clinical Excellence that the drugs should be prescribed only to patients in the later stages of the disease. They were granted a judicial review—the first time one of NICE's decisions had been challenged in this way—and while the judge upheld one part of the challenge, the other two parts were dismissed and NICE's guidance stands.
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September 1, 2007
By:
Daniel Kracov, Arnold & Porter
The history of prescription drug laws is a complex mix of evolution and politics—in particular, the politics following real or perceived public health crises. The bipartisan PDUFA IV legislation currently pending in Congress is no exception: The bills—the Senate FDA Revitalization Act (S. 1082) and the House FDA Amendments Act (H.R. 2900)—would both continue existing programs and create new regulatory burdens.
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September 1, 2007
By:
David Davidovic, Genentech
Much has been said about the need and imperative for life science companies to comply with the various laws and regulations that govern our industry. More recently, state-level marketing laws have proliferated, adding new rules of the road and resulting in thousands of hours and millions of dollars for training, tracking, reporting, consulting, analysis, and support systems.
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July 30, 2007
By:
Jill Wechsler
Twelve years is probably "the best deal the industry is going to get," comments former FDA official Scott Gottlieb. "This is a genuine compromise."
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July 3, 2007
We'll see a more coordinated, worldwide platform not just for marketing, but for R&D and regulatory because of the harmonization that is slowly coming, primarily between Japan, Europe, and the United States
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