Currently viewing the tag: "FDA"

Gwyneth Paltrow’s wellness website, Goop, has grown substantially in recent years along with the general surge of health culture’s popularity. Paltrow started the venture back in 2008 as newsletters for food recipes, but upon the advice of a business savvy friend, she quickly expanded the content of those letters to a much wider […]

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On September 3, Swiss-based pharmaceutical giant Novartis launched the first American “biosimilar”—a copycat version of a complex biologic drug.  Novartis is offering it’s product Zarxio at a wholesale price that is 15% less than the wholesale price of the product it mimics: […]

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International Cybertheft on the Rise

On October 22, 2014 By

In the wake of the government’s indictment against members of Unit 61398, the Shanghai-based cyberunit of the People’s Liberation Army, economic cybertheft against private industries continues to rise. Last week, the FBI issued a private warning to industries that another high-level group of Chinese hackers […]

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The Medical Device Amendments of 1976 (MDA), to the Food, Drug, and Cosmetic Act (FDCA), divide medical devices into three classes according to user risk. Class I devices pose the least risk; Class III devices pose the most. Class I devices are subject to general controls such as labeling requirements. Class II devices are subject to […]

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Monday Morning JetLawg

On February 7, 2010 By

In the news . . .

Google and NSA team up to fight cyberattacks.

Scientists discover energy teleportation.

Seventh Circuit upholds prison ban on Dungeons & Dragons against First and Fourteenth Amendment challenge.

Australian copyright holders lose ability to compel ISP assistance. Meanwhile, new Aussie […]

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Monday Morning JetLawg

On November 22, 2009 By

In the news . . .

Wired writer tries to find out if it’s possible to disappear in the digital world.

England’s proposed new copyright laws are extremely controversial.

Insurance company takes away Canadian woman’s long-term sick leave benefit after Facebook photos indicate she wasn’t suffering from depression.

Sony […]

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In September 2009, the FDA adopted a new regulation banning flavored tobacco. The ban specifically targets candy and fruit-flavored cigarettes. While this issue may be obscure to some, for others, it’s a big deal–their favorite brands of cigarettes have been made illegal with little public debate while the country is occupied with a tanking economy […]

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Marketing Has a High Price Tag for Pfizer

On September 9, 2009 By

Pfizer offered a major “mea culpa” last week when it agreed to pay $2.3 billion in fines for the “largest combined federal and state health care fraud settlement in the history of the Department of Justice.” The pharmaceutical company has ended up in this less than esteemed position as a result of its […]

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Biosimilar Bills Foment Heated Debate

On July 23, 2009 By

Most people agree that a generic biologics pathway for the U.S. Food and Drug Administration (FDA) approval of these drugs would be a boon to consumers, but different parties seem to be at odds on the exact exclusivity period that the pharmaceutical companies should be given from their generic drug competitors.

These generic biologics […]

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