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  • Regulatory NewsRegulatory News

    FDA Authorizes Use of Investigational Diagnostic to Screen Blood Donors for Zika

    The US Food and Drug Administration (FDA) on Wednesday said it will permit the use of an investigational blood test to screen donated blood for the Zika virus. In a statement, the agency said it is allowing the test, developed by Roche Diagnostics, to be used to screen blood in areas, such as Puerto Rico , where the virus is actively transmitted. When reached for comment, Roche spokesman Bob Purcell told Focus that screening with the test will begin "in the next few ...
  • Regulatory NewsRegulatory News

    WHO on Prequalified IVDs: Changes Must be Reported

    Manufacturers of prequalified in vitro diagnostics (IVD) must submit change reports to the World Health Organization or risk having their product de-listed from the compendium of prequalified IVDs. Reportable changes, according to new WHO draft guidance issued late last week, include: Changes to the IVD or how it’s manufactured that have the potential to impact an IVD’s function, performance, usability or safety Changes to a company’s quality management system (QMS), ...
  • Regulatory NewsRegulatory News

    House Committee Floats Draft Bill for New FDA Regulations of In Vitro Clinical Tests

    In advance of a hearing next Thursday, the House Energy & Commerce Committee has released a draft discussion bill that would set up new regulations for in vitro clinical tests. The 185-page draft bill lays out how it would create a new Center for In Vitro Clinical Tests within the US Food and Drug Administration (FDA). And although the bill refers to the tests as "in vitro clinical tests," it remains to be seen how FDA would regulate the tests differently from  in ...
  • Regulatory NewsRegulatory News

    How Many Drug Companies Manage to Get Two New Drugs Approved by FDA? Not Many

    The development of a new pharmaceutical or biopharmaceutical product is a notoriously difficult process. According to industry data compiled by the Tufts Center for the Study of Drug Development, only about one in 10 drugs entering into Phase I clinical trials will ever be approved by the US Food and Drug Administration (FDA)—and those are just the companies whose drugs actually made it to the clinical development stage.  Getting a drug approved, in other words, can feel ...
  • Regulatory NewsRegulatory News

    FDA Provides Some Clarity to Complex Regulatory Environment for Molecular Diagnostics

    A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) aims to clarify the regulatory processes by which certain molecular diagnostic devices are approved or cleared by federal regulators. Background As FDA explains in its guidance document, Molecular Diagnostic Instruments With Combined Functions , molecular diagnostic instruments are "critical components of certain in vitro diagnostic device...
  • 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 ...
  • 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...
  • Feature ArticlesFeature Articles

    Regulatory Perspectives on Companion Diagnostics

    Companion diagnostics offer a revolutionary approach for redefining the traditional fields of pharmacology and disease diagnostics. They support the drive toward personalized medicine by taking advantage of the wealth of information being derived from the human genome. In short, these diagnostic tools do not simply validate or confirm the presence of a genetic marker associated with a disease process but can offer wide-ranging benefits in improving the accuracy of therapy...
  • NICE Restricts GE's Diagnostic Test to Research Use

    General Electric (GE) Healthcare's diagnostic test (SeHCAT) for bile acid malabsorption in patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and Crohn's disease without ileal resection has been restricted for research use by the National Health Service (NHS) according to  draft guidance  issued yesterday by the National Institute for Health and Clinical Excellence (NICE).  The draft recommends restricting SeHCAT to research settings in or...
  • 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 ...