Category Archives: FDA

US FDA Commissioner Margaret Hamburg to Keynote O’Neill Institute Summer Program on Emerging Issues in Food and Drug Law

The Commissioner of the United States Food and Drug Administration, Margaret Hamburg will provide the keynote address to the O’Neill Institute for National and Global Health Law’s Summer Program on Emerging Issues in Food and Drug Law. Margaret A. Hamburg became the 21st commissioner of food and drugs on May 18, 2009. The second woman […]

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Posted in FDA, Global Health, National Healthcare, Tobacco, Trade, Uncategorized; Tagged: , , , , , .

July 14-18 – Emerging Issues in Food and Drug Law (O’Neill Institute Summer Program with Confirmed Speakers)

Please join the O’Neill Institute for National and Global Health Law at Georgetown University for a one-week intensive summer institute exploring the domestic and international legal, regulatory, and policy framework shaping the safety and availability of foods and medicines worldwide. The program will cover U.S. domestic law including recent laws and regulations; international regulatory harmonization […]

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Posted in FDA, Global Health, Health reform, National Healthcare, Tobacco, Trade, Uncategorized; Tagged: , , , , .

Is obesity the ticket to fighting antibiotic resistance?

Research points to the possibility that taking antibiotics could lead to weight gain. Could this reality be the necessary catalyst to change the way we use antibiotics in general?Antibiotic overuse is a public health crisis. For decades, scientists have supported changing antibiotic prescribing practices in response to the alarming consequences of their overuse – most […]

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Posted in FDA, Global Health, National Healthcare, Uncategorized; Tagged: , .

Do prescription drugs need a message?

The recent controversy surrounding a relatively new blood thinner called Pradaxa (dabigatran) centers not on the drug itself, but on the safety of the drug’s message. Brought to market as a superior product to the long-standing market leader, Coumadin (warfarin), Pradaxa is touted for its ability to treat atrial fibrillation without the inconvenience of frequent […]

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Posted in FDA, National Healthcare;

Toward a Smoke-Free Generation: FDA Launches Tobacco Education Campaign for Teens

On February 11, 2014, the FDA launched “The Real Cost” education campaign, aimed at preventing at-risk youth from using tobacco and reducing the amount of teenagers who become regular smokers. In 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act, granting the FDA the authority to regulate tobacco. The campaign […]

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Posted in FDA, Global Health, Health reform, Tobacco; Tagged: , , , , , , , , , , , , .

FDA Issues Guidelines on Use of Antibiotics in Livestock

On December 11, 2013, the Food Drug Administration (FDA) issued guidelines aimed at phasing out the use of antibiotics that are critical to human health in food-producing animals,  including penicillin, azithromycin and tetracycline. Aside from treating infections in animals, livestock producers have been using antibiotics to induce growth in an animal and maximize feed. The […]

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Good Riddance to U.S. Trans Fats

The Food and Drug Administration (FDA) has been subject to frequent criticism for its lax oversight of food safety, and particularly of food additives. However, this morning the agency stepped out ahead of most of its international peers, submitting for public comment a new determination that would effectively remove partially hydrogenated oils (PHOs), the primary […]

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The Breast Milk Market and the Need for Clearer Rules

    Source: CDC A study published in Pediatrics by researchers at Nationwide Children’s Hospital in Columbus, OH has been in the news (ABC News; Wall Street Journal; New York Times) after they found that 72% of the breast milk samples they purchased online contained infection-causing bacteria. This comes after increased awareness and promotion of […]

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Public Health Math: Does “less bad” = “good”? A look at the increasing popularity of e-cigarettes

The field of public health is premised on epidemiological number games. While eradicating disease may be the paragon of the field, in practice, public health leaders apply a more rational lens focused on achieving the best health outcomes for the majority.  Tackling the health issues associated with tobacco products presents a ripe example of this […]

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Posted in FDA, Tobacco;

Will FDA Turn the Tide on Industry-wide Medical Product Development?

The advent of big data has forced a sea change throughout the scientific research enterprise, shaking the industry’s fundamental attitude towards the data themselves. Data is now understood as the currency of research. Consequently, industry is warming to the new reality that legal norms once considered to drive business – confidential commercial information, trade secrets […]

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Posted in FDA, Health reform, National Healthcare, Updates; Tagged: , , , .

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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