FDA

  • Read more: A “Torrent of Studies” on Direct-to-Consumer Advertising: Is FDA Shoring Up Its Defenses?
    Article

    A “Torrent of Studies” on Direct-to-Consumer Advertising: Is FDA Shoring Up Its Defenses?

    By Kate Greenwood Cross-Posted at Health Reform Watch At Regulatory Focus earlier this week, Alexander Gaffney wrote about what he characterized as “a torrent of studies” that FDA is conducting or has proposed conducting on prescription drug promotion, and, in particular, on direct-to-consumer advertisements.  The studies include, among others, a survey study aimed at sussing out “the influence of DTC advertising in…

  • Read more: Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies
    Article

    Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

    By Mary Ann Chirba, J.D., D.Sc., M.P.H. and Alice A. Noble, J.D., M.P.H. Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell [1] came on the heels of Sir John B. Gurdon…

  • Read more: A Decade’s Quest for Safer Drugs: Congressional Committee Green Lights Regulation of Drug Supply Chains and Compounding Manufacturers
    Article

    A Decade’s Quest for Safer Drugs: Congressional Committee Green Lights Regulation of Drug Supply Chains and Compounding Manufacturers

    By Mary Ann Chirba and Alice A. Noble On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment).  Congressional efforts to enact comprehensive legislation to improve…

  • Read more: Life Cycle of the Fight to Label Innovative Ingredients Introduced Into Consumer Products – A Suggestion for Producers of Lab Grown Meat
    Article

    Life Cycle of the Fight to Label Innovative Ingredients Introduced Into Consumer Products – A Suggestion for Producers of Lab Grown Meat

    By Katharine Van Tassel Manufacturers assert that they have no obligation to provide consumers with notice through labeling when ingredients created through innovative technologies are introduced into consumer products designed for human consumption. On the other hand, consumers take the position that they have the right to know what ingredients are in these products, especially…

  • Read more: Regulatory Concepts in the News, Part I: FDA Efficacy Standards for Old Drugs
    Article

    Regulatory Concepts in the News, Part I: FDA Efficacy Standards for Old Drugs

    By Patrick O’Leary While reading some of the great articles from the health section of the New York Times over the holidays it struck me that such articles, in their need to be concise and accessible, often give only passing treatment to regulatory concepts that can be fundamental to the story. Accordingly, I thought it…

  • Read more: Film Review: How to Survive a Plague
    Article

    Film Review: How to Survive a Plague

    By Suzanne M. Rivera How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today.  Beginning at the start of the epidemic, when little was known about the HIV…

  • Read more: Tools for Teaching the Fungal Meningitis Outbreak
    Article

    Tools for Teaching the Fungal Meningitis Outbreak

    By Jennifer S. Bard I’m sure many of us are talking about the contaminated steroid injections which have spread a fungal form of meningitis Exserohilum rostratum across the country.   The CDC, which as is usually the case is doing an excellent job of providing clear and current information,  reports that as of “October 17, 2012,…

  • Read more: Reporting Information about Clinical Trial Data: Passing the Torch from HHS to the FDA
    Article

    Reporting Information about Clinical Trial Data: Passing the Torch from HHS to the FDA

    By Leslie Francis In 2007, motivated by concerns that pharmaceutical companies were not sharing negative data about what had been learned in clinical trials, Congress established enhanced reporting requirements. A series of articles published in January 2012 in the British Medical Journal demonstrates that data reporting remains deeply problematic, especially for industry-sponsored trials. (The articles…