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Category Archives: FDA

12.13.13

FDA Issues Guidelines on Use of Antibiotics in Livestock

By Ana S. Ayala

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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11.07.13

Good Riddance to U.S. Trans Fats

By Daniel Hougendobler

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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10.23.13

The Breast Milk Market and the Need for Clearer Rules

By Phoebe Ramsey

    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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09.17.13

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

By Aliza Glasner

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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07.22.13

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

By Aliza Glasner

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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04.30.13

The Power of Sharing: Rethinking the Future of Intellectual Property and Biomedical Research

By Aliza Glasner

Recently, the U.S. Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Case No. 11-725, on the eligibility of patenting the BRCA1 and BRCA2 genes, which identify hereditary breast and ovarian cancers. The Court granted certiorari to hear this case after a split developed among the United States circuit court of […]

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12.31.11

Lawsuit Offers Hope that the Plan B OTC Age Restrictions may yet be Lifted

By Kelli K. Garcia

The fight to make Plan B, an emergency contraceptive, more widely available continues despite Health and Human Services Secretary, Kathleen Sebelius’ decision earlier this month to overrule the FDA’s recommendation that Plan B be made available over-the-counter (OTC) to women and girls of all ages. The Center for Reproductive Rights (CRR) will reopen a lawsuit, […]

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12.16.11

Judge invites challenge to HHS decision that blocked access to emergency contraception

By O’Neill Institute

Originally posted at Hunter of Justice on December 14, 2011. The Center for Reproductive Rights announced Tuesday that it will reopen a lawsuit filed in 2005 in order to challenge unnecessary age restrictions on emergency contraceptives imposed last week by the Obama administration. The lawsuit – Tummino v. von Hamburg –  was originally filed against […]

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11.22.11

Court Enjoins FDA Tobacco Labels

By O’Neill Institute

This post was authored by O’Neill Institute research assistant and third-year Georgetown University Law Center student Mirona Dragnea. On November 7, 2011, District Judge Richard J. Leon of the D.C. District Court sided with five tobacco companies in granting a preliminary injunction in R.J. Reynolds v. U.S. FDA. The decision prohibits the United States Food […]

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08.01.11

What Does It Mean to Inform?

By O’Neill Institute

This post was authored by Sam Halabi, J.D., M.Phil., Assistant Professor, University of Tulsa College of Law. What Does it Mean to Inform? In response to the graphic warnings released by the U.S. Food and Drug Administration on June 21, 2011, tobacco firms have asserted that the warnings violate their First Amendment rights by forcing […]

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The views reflected in this expert column 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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