The documents related to sponsors, clinical trials, overseas regulatory status, names of experts consulted and post-marketing safety reports.
Eisai, are also required to conduct six post-marketing studies to further evaluate adverse effects of lorcaserin on heart valves.
The FDA gave the drug accelerated approval, and Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit.
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Clinical trials and post-marketing monitoring of Gardasil, made by Merck, and Cervarix, made by GlaxoSmithKline, showed side effects similar to placebo.
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Fingolimod for MS has been approved, but the FDA has required that TEN different post-marketing studies be done looking at a variety of safety and outcome parameters.
"While I don't think that a separate office for post-marketing surveillance is likely, a strengthened Office of Drug Safety is almost a certainty, " says David Kessler, a former FDA commissioner who is now a dean at the University of California, San Francisco.
We are at another inflection point, as we move from digital marketing as a renegade effort to post-digital marketing.
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As she moves between guises, her lyrics begin to read like Post-its from a marketing meeting.
In the typical production supply chain for consumer products, of which apparel production is a good example, the higher-value, pre-manufacturing activities like designing, engineering, and branding, and post-manufacturing activities like marketing, warehousing, transporting, and retailing happen in the United States, while the mostly lower-end manufacturing and assembly activities take place abroad.
The post-PC world is a marketing term for the rise of another set of shapes, as they become able to accomplish the desired set of tasks.
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At this point they were living in Marina del Rey, and Rosen was working as director of marketing for a post-production firm in Santa Monica.
The stock, already a hedge fund battleground, dropped on a New York Post report that the multi-level marketing firm is the subject of a law enforcement investigation.
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General Motors this evening took the wraps off the seventh generation Chevrolet Corvette, a 450-horsepower high-tech American sports car that says as much about GM in the post-bankruptcy era as any financial spreadsheet or marketing campaign.
Her post-graduation hopes for a big-city career marketing consumer products were dashed.
After 24 years at Anheuser-Busch I knew upon leaving my post as marketing chief last year, one of the things I was certain to miss was the adrenaline of the Super Bowl advertising process.
But rather than rewrite them, he has launched an email-marketing campaign that urges past customers to post product reviews to the site.
In a previous post, I referenced the abundance of year-end predictions in the PR, marketing and media spheres.
Among the increasingly popular marketing vehicles, due in part to shrinking advertising budgets, are pre- and post-show parties.
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