Latest

  • FDA

    mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes

    By Dan Vorhaus and Phil Ross (cross-posted from Genomics Law Report) For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to…

    mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes

  • Announcements

    Introducing Cristiane Avancini Alves

    We’re excited to introduce and welcome Cristiane Avancini Alves  as a guest blogger for the month of December.

    Introducing Cristiane Avancini Alves

  • FDA

    First Amendment & Pharma: Taking Freedom of Information Seriously

    By Frank Pasquale Back in 2011, the AJLM had a symposium issue anticipating major issues in 1st Amendment limits on FDA restrictions on off-label marketing. It was a prescient move, as Prof. Robertson’s post shows. Just as…

    First Amendment & Pharma: Taking Freedom of Information Seriously

  • FDA

    Court Says Off-Label Promotion is Legal, and the Difference Between Warrant and Truth

    By Christopher Robertson Invoking the First Amendment protection of speech, the Second Circuit today reversed a criminal conviction for a drug salesman’s promotion of a drug beyond its FDA-approved uses.  The case in U.S. v.…

    Court Says Off-Label Promotion is Legal, and the Difference Between Warrant and Truth

  • Bioethics

    The Capacity of Surrogate Decision-Makers

    By Susannah Rose During my many years in healthcare as a clinician, researcher and hospital ethics consultant, I am dismayed by how little relative attention is given to ensuring that surrogate decision-makers (or “proxies”) have…

    The Capacity of Surrogate Decision-Makers

  • Bioethics

    What’s In a Name?

    By Suzanne M. Rivera, Ph.D. In regulatory and research ethics circles, it is fairly common to hear people say they prefer the term “research participant” to “research subject” because they feel it’s more respectful.  They…

    What’s In a Name?

  • Student Fellows

    Upcoming Discussion: “The Objectivity of Ethics and the Unity of Practical Reason”

    By Yu-Chi Lyra Kuo Katarzyna de Lazari-Radek and Peter Singer have an interesting new article in the most recent issue of Ethics on “The Objectivity of Ethics and the Unity of Practical Reason.” Abstract: Evolutionary accounts of the…

    Upcoming Discussion: “The Objectivity of Ethics and the Unity of Practical Reason”

  • Bioethics

    Twitter Round-Up (11/25-12/1)

    By Casey Thomson From policy adoption at the federal level to debate over the health concerns of political figures, this week’s round-up focuses largely on the news for bioethics and health law in the realm…

    Twitter Round-Up (11/25-12/1)

  • Weekly Round-Up

    Petrie-Flom Interns’ Weekly Round-up: Nov 17-Nov 30

    By Kathy Wang and Hyeongsu Park In the ongoing medical and legal battle over the deadly meningitis outbreak, the victims  have been trying to freeze nearly $500 million in assets. US District Judge Dennis Saylor…

    Petrie-Flom Interns’ Weekly Round-up: Nov 17-Nov 30