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  • Regulatory NewsRegulatory News

    Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements

    Boehringer Ingelheim has questions on how new US Food and Drug Administration (FDA) draft guidance on optional child-resistant packaging (CRP) statements will benefit health care professionals and consumers. The draft guidance , released 2 August, offers help for drugmakers looking to use the statements and ensure they are clear, useful, informative and, to the extent possible, consistent in content and format. Boehringer, however, questions "whether thi...
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    FDA Approves 6th Biosimilar in US, Second for Humira

    The US Food and Drug Administration (FDA) announced Friday that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira (adalimumab). Cyltezo, which follows the approval of Amgen's Amjevita (adalimumab-atto) last September , has been approved for multiple indications (see link to label below), did not go before an FDA advisory committee and was not approved as an interchangeable biosimilar. How...
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    Asia Regulatory Roundup: CFDA Expands Trial Data Quality Monitoring Drive to Cover Medical Devices (11 July 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Boehringer, J&J Pressure TGA to Bring ‘Out of Date’ Advertising Framework into Digital era Boehringer Ingelheim and Johnson & Johnson have called for the Australian regulator to bring its advertising framework into the digital era. The Therapeutic Goods Administration (TGA) stands accused of operating an out-of-date framework that has failed to adapt to the rise of ad...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: When is an App a Medical Device? MHRA Explains (25 August 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Updates Guidance on Determining Whether an app is a Medical Device The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance on determining whether an app is classified as a medical device. The new guidance features revised flowcharts to help software developers understand whether an app needs a CE mark. MHRA released ...
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    Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels

    Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label. The comments come as FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product. However, th...
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    Boehringer Ingelheim Warns MHRA of Reckitt Benckiser’s Misleading TV Advertisement

    It’s well known that competition among pharmaceutical companies is fierce, and a misstep, usually in a clinical trial, can result in millions, if not billions of dollars lost. And now a glimpse of that competition is boiling over into the realm of television advertising. In a case from April, made public by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday, Boehringer Ingelheim called on the MHRA to pull a television advertisement for Reckitt ...
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    Government Watchdog: FDA Took 'Lax or Permissive' Approach to Pradaxa Approval

    The US Food and Drug Administration's (FDA) judgments regarding the clinical trial and approval of Boehringer Ingelheim's blood thinner Pradaxa (dabigatran) reveal "a lax or permissive approach," according to a new report from the Project On Government Oversight (POGO). Approved by FDA in 2010 to prevent blood clots in patients with atrial fibrillation, POGO chose to investigate the approval of Pradaxa because it's been suspected of contributing to thousands of patient d...
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    Bayer, Boehringer Latest to be Hit by Indian Patent Office Decisions

    In two recent decisions, India’s patent office struck major blows to German drug makers Bayer and Boehringer Ingleheim, saying their respective patents for Nexavar and Spiriva fail to meet the inventiveness requirements under the country’s controversial Patents Act . Background India’s patent system has been a source of frustration for western drug makers, who have argued for intellectual property (IP) reform in the country. India is also listed on the US Trade Repre...
  • Boehringer Ingelheim's Blot Clot Drug Cleared for NHS Use

    The UK's National Institutes of Health and Clinical Excellence (NICE), the country's cost containment agency, has cleared the use of Boehringer Ingelheim's alteplase (Actilyse) for the treatment of acute ischaemic stroke by the National Health Service (NHS) in  final guidance  issued on 26 September.   The guidance recommends starting treatment as early as possible within 4.5 hours after onset of stroke symptoms, and after intracranial haemorrhage has...