Regulatory - Pharmaceutical Executive

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New developments and strategies for success in dealing with FDA, OIG, SEC, EMEA, and more.

Comparative Effectiveness Research: Coming Soon?
March 24, 2009
Only time will reveal CER's true definition, and determine the full effects of a CER-based system
FDA's Approvable Problem
November 1, 2007
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?
Practical Tips for Mitigating Risk
October 1, 2007
Want to keep your medical education program on the straight and narrow? Consider peer review.
Some Alzheimer's Patients Left Behind
October 1, 2007
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.
The Complete Pharm Exec Guide to PDUFA
September 1, 2007
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.
Pharma Companies Hit With Warnings for Search Marketing
April 8, 2009
FDA Demands Pharma Firms Pull Unapproved Drugs
April 1, 2009
Massachusetts Passes New Sales and Marketing Rules
March 18, 2009
GSK Garners FDA Warning Letter for Extraterrestrial Ad Campaign
March 4, 2009
Wyeth Loses Preemption Battle
March 4, 2009
5th Annual Process Excellence Week for the Service & Transactional World
Sep 21, 2009 - Sep 24, 2009
Chicaco, IL
BioNetwork 2009
Oct 5, 2009 - Oct 7, 2009
Laguna Niguel, CA

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