• Regulatory NewsRegulatory News

    How Many Drugs has FDA Approved in its Entire History? New Paper Explains

    Pop quiz: While the US Food and Drug Administration (FDA) approves dozens of drugs each year, how many new drugs—i.e. discounting generic versions of approved drugs—has it approved in its entire existence? Until recently, the answer to that question wasn't easy to find. You couldn't find the answer on FDA's website, and even digging into FDA's so-called "Orange Book," which contains a list of all approved drugs and their generic equivalents, wouldn't give you a complete ...
  • Regulatory NewsRegulatory News

    FDA Guidance Aims to Clarify Development of Medical Countermeasures

    A new final guidance document issued by the US Food and Drug Administration (FDA) aims to make it easier to develop in vitro diagnostic devices (IVDs) intended to act as microbiological or medical countermeasures. The guidance document, Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices , is specifically aimed at those IVDs which are intended to simultaneously detect 20 or more pathogens extracted from a single sam...
  • Regulatory NewsRegulatory News

    FDA Finalizes Policy on Use, Approval of Companion Diagnostics

    The US Food and Drug Administration (FDA) has released a long-sought final guidance document on in vitro diagnostic (IVD) companion diagnostic (CDx) products—products intended to help guide the therapeutic use of new medicines based on a consumer's genetic characteristics. Background Regulators and industry have both been touting the benefits of companion diagnostics in recent years as the products have become, in the words of FDA, "more common." The benefits to both ...
  • Feature ArticlesFeature Articles

    Impact of Clinical Utility Requirements on In Vitro Diagnostic Assays

    The term "clinical utility" has come into increasingly common usage as healthcare stakeholders direct greater attention to the determination and establishment of the value of healthcare services, interventions and technologies. The meaning differs somewhat among the various stakeholders depending on their roles and interests. For example, one Medicare contractor (Palmetto) describes its requirement for evidence of clinical utility as "demonstrates change in physician trea...
  • Fitch Report Says NME Approvals Plummet at FDA in Q1, but FDA Data Paint Alternate Picture

    When trying to gauge the success of both the US pharmaceutical sector and the US Food and Drug Administration (FDA), one metric usually reigns supreme: approvals. But despite progress by the latter in shoring up its flagging approval numbers in recent years, a new report indicates the first quarter of 2014 was the worst quarter for approvals in almost 15 years. Background FDA approvals over the last decade have experienced their ups and downs. Consider the following ch...
  • Newly-Approved Companion Diagnostic Promises Personalized Therapy for Lung Cancer Patients

    US regulators on Tuesday announced the approval of the US' first companion diagnostic test to detect a gene mutation associated with a type of lung cancer, giving lung cancer patients a similar diagnostic tool now available to patients with breast cancer. Background The product, approved 14 May 2013, is known as the Cobas EGFR Mutation Test, and acts as a companion diagnostic test to the already-approved cancer drug Tarceva. The drug's manufacturer, Astellas, wrote in a...
  • NICE Green Lights IVD for Breast Cancer Diagnosis

    The UK's cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has agreed to recommend the use of an innovative new diagnostic test designed to guide the use of chemotherapy in patients with early breast cancer. Specifically, the recommendation covers the use of Oncotype DX in patients in the early stages of oestrogen receptor positive (ER+), lymph node negative (LN-) and human epidermal growth factor receptor 2 negative (HER2-) breast...
  • Untitled Letter Targets Unapproved HIV Testing Device Posing as Approved Product

    A new untitled letter sent by US regulators to an Internet domain hosting company alleges that the company marketed an unapproved diagnostic test capable of testing for HIV, thereby violating federal law. Background HIV diagnostic kits were only recently approved for over-the-counter (OTC) sales. In July 2012, the US Food and Drug Administration (FDA) approved OraSure's In-Home OraQuick HIV test after its Blood Products Advisory Committee overwhelmingly supported its ...
  • FDA Beefs up Medical Countermeasure Program with new 510(k) Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry regarding the development of In Vitro devices capable of detecting the presence of several types of dangerous pathogens, its latest effort in a long-running strategy to develop medical countermeasures (MCMs). The guidance, released 9 November 2012, specifically addresses the unique needs of conducting clinical trials on such a device. The clinical testing of products used to tr...
  • 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...
  • Companion Diagnostic Test, Drug Get Concurrent Approval from FDA

    A companion diagnostic test developed by Manchester, England-based QIAGEN and marketed by Bristol-Myers Squibb and Eli Lilly and Company has won approval from the US Food and Drug Administration (FDA) for determining whether the anti-colorectal cancer (CRC) drug Erbitux (cetuximab) will be effective in patients. The product, known as the Therascreen KRAS RSQ PCR Kit, screens patients for the presence or absence of a particular mutation in the KRAS gene. If the KRAS gene ...
  • Feature ArticlesFeature Articles

    Nanomedicine: Current Regulatory Scenario and Prophylactic Regulatory Strategies

    "According to Global Industry Analysts Inc. report on nanomedicine, commercialization of this tiny technology is surging at a steady rate and is expected to exceed $160 billion by 2015." 1 What is Nanomedicine? In simple terms, nanomedicine (NM) is nanotechnology-enabled medicine. 2 It is the science and technology of diagnosing, curing and preventing a disease, repairing damaged tissues and preserving human health using molecular tools and molecular knowledge of the ...