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  • FDA Enacts New Class-wide REMS Policies for Opioids

    The US Food and Drug Administration (FDA) announced 9 July the approval of a new Risk Evaluation and Mitigation Strategy (REMS) for the most potent opioid products on the market, saying in a statement that the new policies are meant to balance patient access and safety measures to improve the safe use of the products. The new REMS policy will cover all extended-release (ER) and long-acting (LA) opioid products, and will rely primarily on educational products, which the m...
  • US Regulators Move to Reclassify Medical Device as Class III

    The US Food and Drug Administration (FDA) announced Friday, 6 July that it wants to require sponsors of shortwave diathermy (SWD) devices to file either a premarket approval application (PMA) or complete a product development protocol (PDP) for all but one of the device's indications. SWDs are used to generate deep heat in body tissues using electromagnetic energy. Though they are primarily used to raise the heat of the body tissue, some medical device manufacturers have...
  • US Regulators Reclassify Pacemaker Electrodes as Higher-Risk Devices

    • 06 July 2012
    After a series of problems in which permanent pacemaker electrodes have been associated with adverse events, the US Food and Drug Administration (FDA) said it will reclassify the electrodes as Class III medical devices. As a result of the reclassification, manufacturers of permanent pacemaker electrodes will now be required to submit either a premarket approval application (PMA) or complete a product development protocol (PDP) in order to legally market a permanent pacema...
  • New Draft Guidance Establishes Special Controls for Blood Access Devices

    The US Food and Drug Administration (FDA) plans to reclassify and implement new special controls for blood access devices used in hemodialysis. In a 19 June 2012 Federal Register posting, FDA announced the release of its Draft Guidance for Industry and Staff: Class II Special Controls Guidance - Implanted Blood Access Devices for Hemodialysis , which it said serves "as the special control for implanted blood access devices." The draft guidance follows another Federal...
  • Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit

    • 12 June 2012
    The Supreme Court of the United States (SCOTUS) said it agreed to hear a challenge from life sciences manufacturer Amgen regarding a lawsuit alleging the company inflated its stock price by misleading investors about the safety of its anemia drugs, Aranesp and Epogen. Amgen is reportedly contesting the class-action nature of the lawsuit, which it says could have the perverse effect of placing severe financial pressures on companies if allowed to stand. "At issue," expla...
  • Study: FDA Recall Communication System Ineffective, Poorly Designed

    It can be difficult to keep up with the dizzying number of drug recall notices sent by the US Food and Drug Administration (FDA). So difficult, in fact, that the agency seems to miss a significant number of recall notices itself, says a new study. The study, published in the Archives of Internal Medicine, finds FDA's recall information communication systems are sorely lacking, failing to disseminate information for as approximately 20% of all recalled medical products ...
  • Bill Introduced to Speed Development and Review of Breakthrough Therapies

    A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA). The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies , would amend the FD&C Act  to include pr...
  • Pfizer Executives Sued Under Securities Laws for Allegedly Concealing Clinical Trials Results

    • 02 April 2012
    A federal judge refused to dismiss a case against Pfizer and five former executives for allegedly violating federal securities law by concealing clinical trial results, reports The Courthouse News Service . The class action lawsuit, filed by the Teacher's Retirement System of Louisiana, accuses the company and executives of violating federal securities laws by omitting the results of unfavorable clinical trials from public filing statements made by Pfizer. The defendan...
  • FDA Establishes Class II Controls for Full Field Mammography System

    The US Food and Drug Administration (FDA) released new guidance on 27 March establishing Class II Special Controls for full field digital mammography systems (FFDMS), bringing the device class under the 510(k) approval pathway. The guidance, Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System , includes advice on the evaluating risks to human health, electrical safety precautions, biocompatibility, phy...
  • Near Infrared Brain Hematoma Detectors Classified as Class II Medical Devices by FDA

    The US Food and Drug Administration (FDA) issued a final rule classifying Near Infrared (NIR) Brain Hematoma Detectors as class II medical devices requiring special controls on 22 March. The rule is in response to a petition issued by InfraScan Inc., which asked FDA to classify its Infrascanner Model 1000 device-previously found by FDA to be class III-as a class II device instead. FDA agreed with their assessment, and identified the inherent risks of the device and miti...
  • FDA Proposes Lowering Risk Classification for Devices Used to Detect Tuberculosis

    The US Food and Drug Administration (FDA) is calling for the reclassification of devices used to detect cases of tuberculosis (TB), lowering the current risk classification in a move that it hopes will streamline the clearance pathway for medical devices. "Currently, these tests are Class III (high-risk) devices that require the more rigorous pre-market approval application," said FDA in a statement released on their website 16 March 2012. FDA is proposing to downclass...
  • US DEA Releases Fee Schedule for Chemical Registrations

    The US Drug Enforcement Administration (DEA), a division of the US Department of Justice (DOJ), released an updated adjustment of the registration and reregistration fees associated with its Diversion Control Program on 13 March. The program is used by DEA to control the manufacture, distribution, dispensing, importation and exportation of controlled substances and List I chemicals. List I chemicals are those deemed to be important in the manufacture of controlled subst...