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    OpenFDA Releases Huge Trove of Medical Device Data

    On Monday, the US Food and Drug Administration (FDA) released a vast amount of medical device data to its openFDA platform. Background The openFDA initiative was originally born from an order from the White House , which called for federal agencies to implement a new " digital strategy " to make government information more accessible to the public. The strategy focused on creating APIs – not active pharmaceutical ingredients, but application program interfaces – that ...
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    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
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    FDA Approving New High-Risk Devices at Fastest Pace in Last Decade, Report Finds

    A new analysis by the California Healthcare Institute (CHI) indicates that after years of unprecedentedly high review times, the US Food and Drug Administration is finally beginning to accelerate the pace at which it reviews innovative high-risk medical devices. Background The data, contained in CHI's report, Taking the Pulse of Medical Device Regulation and Innovation , found broad improvement at FDA's Center for Devices and Radiological Health (CDRH), which...
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    Flip a Coin: FDA Approves Kidney Diagnostic With 50% False Positive Results

    Risk and benefit are nothing if not relative concepts. A product can have a laundry list of dangerous side effects, but so long as it treats an even more dangerous indication, it can still be approved by regulators. Conversely, a product may present no side effects whatsoever, but if it lacks efficacy, it might still be rejected by regulators. The very heart of the regulatory process is determining which products ought to be approved, and which ones don't quite pass must...
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    Public Citizen Again Calls for Ban on Diabetes Drug Victoza

    A prominent consumer watchdog group is calling on the US Food and Drug Administration (FDA) to withdraw its approval of the diabetes drug Victoza (liraglutide), which it says is linked to acute pancreatitis and several deaths. Background Victoza was approved by FDA in 2010 as a once-daily injectable treatment for Type 2 diabetes. The drug is an incretin mimetic drug known as a glucon-like peptide-1 (GLP-1) receptor agonist. At the time of its approval, FDA noted...
  • Timing of Complete Response Letter Disclosure Leads to Investigation into Novo Nordisk

    • 10 December 2013
    Danish pharmaceutical manufacturing giant Novo Nordisk is the target of a new investigation into whether the company provided adequate disclosure to its investors regarding the status of two drug products it had sought approval for from the US Food and Drug Administration (FDA). Background The investigation, first revealed by Novo in a 10 December 2013 press statement, regards the complete response letters (CRLs) sent by FDA to Novo on 8 February 2013 for two products, ...
  • FDA Finalizes Extensive Guidance on Pivotal Trials for Medical Devices

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released an extensive new final guidance document on the design of pivotal clinical investigations meant to support the approval of medical devices. The 57-page guidance, Design Considerations for Pivotal Clinical Investigations for Medical Devices , was first released in draft form August 2011 and pertains to the stages of development in which a device is evaluated for s...
  • Sterility Violations Form Basis of FDA Warning Letter to Novo Nordisk

    Life sciences manufacturer Novo Nordisk has been sent a Warning Letter from the US Food and Drug Administration for what regulators said were "significant" deficiencies found at the company's Bagsvaerd, Denmark facility. FDA officials said they were particularly concerned about current good manufacturing practice (CGMP) violations found at the firm, which included practice deviations that could have potentially led to product being manufactured under non-sterile condit...
  • FDA Clears Gastroenteritis Diagnostic Device Through De Novo Pathway

    The US Food and Drug Administration (FDA) has announced the clearance of a new diagnostic test it says is capable of simultaneously testing a sample to identify the presence of any of 11 causes of infectious gastroenteritis. Infectious gastroenteritis is a condition FDA explained is marked by the inflammation of the intestines and stomach, and may be caused by viruses, bacteria or parasites. Some of the most common variants include infections caused by salmonella, shig...
  • 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...
  • FDA Clears Ingestible Medical Device Aimed at Boosting Adherence

    The US Food and Drug Administration (FDA) has cleared an ingestible medical device manufactured by Proteus Digital Health through its de novo clearance pathway, clearing the way for the futuristic device to get to market. The de novo process is used for low-risk novel devices that would otherwise be required to submit a premarket approval (PMA) application and be subjected to expensive clinical trials. Proteus' device, the Ingestion Event Marker (IEM), was described...
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    Orange Book Listings Lesson: An overly broad use code may lead to legal challenges

    The US court system has been busy recently with issues affecting the pharmaceutical industry, including a number of cases involving the Hatch-Waxman Act. On 17 April 2012, the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S marking the first Abbreviated New Drug Application (ANDA) case decided by the high court since the passage of the act in 1984. The Supreme Court has a long history of overturning Federal C...