Regulatory

Jul 01, 2009
By Pharmaceutical Executive Editors
Patents are an important tool for protecting innovative products, uses or processes intended for commercialization. A granted patent provides a limited monopoly, normally for up to 20 years from the filing date of a patent application, giving a patent owner the right to prevent other parties from making, stocking, selling, using or importing the patented invention without the patent owner's permission. A theoretical ideal for an innovator would be to obtain a patent in all countries of the world. However, patents must be sought and enforced in each territory where protection is desired because a global patent does not (yet) exist. For cost reasons, a decision is usually made as to where to file and process patent applications.
Jun 17, 2009
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Feds claim results of study comparing car crash deaths and children on ADHD drugs were not paramount to pulling kids off of ADHD treatments.
Jun 11, 2009
The Word Health Organization just bumped the H1N1 influenza to pandemic alert phase 6 (the highest alert level), making it the first worldwide pandemic in 41 years.
Jun 03, 2009
Pharmaceutical Executive
By Pharmaceutical Executive Editors
The feds green lit a task force charged with easing the flow of communication between FDA, pharma companies, and the general public. While the team is being billed as a task force for transparency, it?s still unclear what is being revealed.
May 27, 2009
Pharmaceutical Executive
By Pharmaceutical Executive Editors
You know those loud soundtracks and distracting visuals during the safety information in your TV ads? Critics have been complaining about them, and new draft guidance from FDA is calling them a "no-no."
Mar 24, 2009
Only time will reveal CER's true definition, and determine the full effects of a CER-based system
Nov 01, 2007
Pharmaceutical Executive
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?
Oct 01, 2007
Pharmaceutical Executive
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.
Sep 01, 2007
Pharmaceutical Executive
By Pharmaceutical Executive Editors
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.
Sep 01, 2007
Pharmaceutical Executive
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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