RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • Judge Orders FDA To Remove Antibiotics from Animal Feed

    A federal judge ruled this week that The US Food and Drug Administration (FDA) must either make plans to withdraw approval for the use of most antibiotics in animal feed or withdraw approval for non-therapeutic use of those antibiotics, reports Reuters . The 22 March ruling by US Magistrate Judge Theodore Katz comes after mounting concerns about antibiotic resistance and emerging so-called "superbugs" being seen as a threat to human health. Katz noted FDA had recently ...
  • Nestle Loses Patent Case That Could Have Stifled IVD Development

    • 20 March 2012
    The Supreme Court of the US (SCOTUS) ruled 20 March that Prometheus Laboratories, a subsidiary of Nestle, could not patent a method to determine the proper dosing for a disease , reports Reuters . The highly-watched court case overturned an earlier-and controversial-decision allowing Prometheus to patent adequate dosing methods. Critics contended Prometheus was patenting observational science itself, preventing physicians from treating their patients, developing new th...
  • Court Upholds FDA Labeling Regulations on Cigarette Packaging

    The Cincinnati Court of Appeals has upheld the US Food and Drug Administration's (FDA) authority to require cigarette companies to adorn their tobacco products with graphic labeling, ruling FDA's advertising regulations do not violate the companies' rights to free speech. "There can be no doubt that the government has a significant interest in preventing juvenile smoking and in warning the general public about the harms associated with the use of tobacco products," wrote...
  • Healthcare Reform Case to go Before SCOTUS in Two Weeks

    • 12 March 2012
    The Supreme Court of the United States (SCOTUS) will hear a series of challenges to the 2010 Patient Protection and Affordable Care Act (PPACA) of 2010 on 26-28 March, marking a historic challenge to a landmark piece of legislation with huge implications for the pharmaceutical, medical device and biotechnology industries. SCOTUS' review of the law will start on 26 March with arguments on whether the Anti-injunction Act ( AIA ) applies to the review of the PPACA . Th...
  • California Supreme Court Looks to Take Up 'Pay for Delay' Case

    The California Supreme Court is set to review a case on so-called 'pay for delay' settlements that see pharmaceutical manufacturers pay generic manufacturers to secure additional months of market exclusivity for their products. The court will review a decade-old class-action lawsuit against Bayer over its pay for delay settlement to Barr Laboratories. Barr was reportedly planning to sell a generic version of Bayer's antibiotic, Cipro (ciprofloxacin). The lawsuit alleges...
  • Ruling on Tobacco Products Could Have Broader Implications for FDA

    A ruling by the DC Circuit Court of Appeals could have broader implications for the US Food and Drug Administration's attempts to regulate products by mandating uniform labeling. In a decision, Judge Richard Leon ruled that FDA was not lawful when it required cigarette companies to label their tobacco products with graphic, shocking images . "The government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that t...
  • DOJ Files 'Groundbreaking' Consent Decree Against Ranbaxy, Company Agrees to 'Remedy Deviations'

    The US Department of Justice (DOJ) filed a Consent Decree of Permanent Injunction against Ranbaxy, an Indian generic drug manufacturer, with the US District Court of Maryland on 25 January. The action was taken on behalf of the US Food and Drug Administration (FDA), which had found manufacturing and data integrity deficiencies at numerous Ranbaxy facilities located in India and a US-based Ranbaxy subsidiary's facility in New York. The consent decree requires Ranbaxy to c...