Regulatory Articles - Pharmaceutical Executive

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

Congressional Investigations: What Every Exec Should Know

August 1, 2011

When faced with legislative scrutiny, be prepared, be truthful, and don't be afraid to say 'I don't know'...

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?

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.

Practical Tips for Mitigating Risk

October 1, 2007

Want to keep your medical education program on the straight and narrow? Consider peer review.

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.

For Compliance's Sake

September 1, 2007

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.

Exclusivity vs. Patents

July 30, 2007

Twelve years is probably "the best deal the industry is going to get," comments former FDA official Scott Gottlieb. "This is a genuine compromise."

Connected Markets, Rob Dhoble

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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