• Regulatory NewsRegulatory News

    FDA, with academic and community partners, launches first pediatric ECG warehouse

    Pediatric electrocardiogram (ECG) data being collected by the US Food and Drug Administration are now available in a first-of-kind data warehouse.   The warehouse, a mirror of a similar data warehouse for adult ECG data, collects and makes available a rich store of information “to enhance cardiac safety review for therapeutic product development for children,” according to a new FDA Spotlight article announcing the launch of the warehouse.   One prong of the wo...
  • Regulatory NewsRegulatory News

    ANSM Committee Delves Into Nitty-Gritty of Fatal French Phase I Trial

    France’s National Agency for Medicines and Health Products Safety (ANSM) released a report this week outlining how its Temporary Specialist Scientific Committee (TSSC) evaluated what went wrong with a first-in-man clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January. ANSM launched its investigation into the Phase I trial in January, which the contract research organization (CRO) running t...
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    FDA Still Reviewing Arizona, Texas Claims on Importing Execution Drugs

    Arizona and Texas continue to battle with the US Food and Drug Administration (FDA) over the legality of importing drugs used in executions, more than two years after a Court of Appeals said the agency cannot allow the imports. Background As Focus  has reported since 2012, FDA has a complicated history with execution drugs, particularly sodium thiopental, which can be used alone or as part of a cocktail intended to execute inmates on Death Row. Issues with the drug...
  • As Battle Rages over Semantics of Compounding Pharmacies, Missouri Calls One an Executioner

    Over the last year, US-based compounding pharmacies have been subject to a lengthy debate over the semantics of their operations. Are their operations compounding, or are they really de-facto manufacturers? Should new categories like "outsourcing pharmacy" be created to deal with large-capacity compounders? But now the state of Missouri has raised the semantics state even further, granting one anonymous compounding pharmacy an unusual title: state executioner. The devel...
  • FDA Loses Major Case Testing its Enforcement Discretion Authority

    The US Food and Drug Administration (FDA) has a complicated history with sodium thiopental, a drug notoriously used as part of a multi-drug cocktail administered to prisoners condemned to death. And complicating the history further is a new ruling by the DC Court of Appeals, which today ruled that the agency may not exercise "enforcement discretion" to allow the drug into the country. Background In recent years, death penalty opponents have been using a deep understandi...
  • Study: Diagnostic Errors Death Equal Breast Cancer Deaths

    • 31 August 2012
    A study by Johns Hopkins researchers claim medical mistakes in the intensive care unit (ICU) kill as many as 40,500 patents per year, as many deaths as breast cancer patients suffer. The researchers examined more than 5,800 autopsy reports from various ICUs. The study said not all missed errors contributed directly to patient death, but that patients in ICU were twice as likely to suffer a fatal misdiagnosis. "Our study shows that misdiagnosis is alarmingly common in th...
  • US Regulators Issue Warning About Implantable Device

    The US Food and Drug Administration (FDA) issued a warning on Friday, 29 June regarding an implantable medical device manufactured by Covidien Plc subsidiary ev3's Onyx Liquid Embolic System , which federal regulators said has been associated with at least nine patients deaths and dozens of adverse events. The device is used to block the flow of blood in affected blood vessels in patients with brain arteriovenous malformations (AVMs) before the vessels are surgically re...
  • Judge's Order Banning Enforcement Discretion Appealed by FDA

    The US Food and Drug Administration (FDA) said it has appealed a decision issued in March 2012 by US District Court Judge Richard Leon, who said the agency erred in allowing a drug commonly used in executions into the country without first testing its effectiveness, reports Bloomberg . The drug, sodium thiopental, has been at the center of numerous courtroom skirmishes between proponents and opponents of the death penalty. Opponents hope that by restricting access to th...
  • Nebraska Raises Stakes in Battle With FDA, Won't Surrender Supply of Controversial Drug

    The state of Nebraska, engaged in an ongoing battle with the US Food and Drug Administration (FDA) over its supply of an controversial anesthetic drug used in executions, confirmed it will defy an FDA order to hand over remaining supplies of sodium thiopental, reports The Associated Press. In a statement released 20 April, Nebraska's state attorney general's office said they believed a court order, issued by Federal District Court Judge Richard Leon, was incorrect. Leon...
  • FDA, South Dakota in Tussle Over Regulation of Lethal Injection Drug

    The US Food and Drug Administration (FDA) is currently embroiled in an escalating fight with South Dakota's government over the regulatory quality-and legal status-of a drug intended to be used to put prisoners to death, reports KSFY News . The drug, an anesthetic known as sodium thiopental, is a staple of a three-drug cocktail commonly used to execute prisoners on death row. Anti-death pentalty advocates have increasingly been targeting the drug, which is no longer p...
  • Court Bars FDA from Importing Drug Used in Death Penalty

    A US District Court judge this week barred the US Food and Drug Administration (FDA) from importing an anesthetic drug used in executions, saying FDA's use of enforcement discretion was "callous" and "disappointing," reports Reuters . "The FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the execution...
  • Study: Poor Health Literacy Detrimental to Patient Health Outcomes

    A new study in the British Medical Journal has found that limited health literacy was associated with higher rates of death among study participants. The study tracked nearly 8,000 patients over the age of 52, and sought to understand the effects of health literacy on patient health. To do this, the study asked patients to read the label of a medicine bottle and answer four simple questions, such as the maximum number of days a medicine may be taken and situations req...