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  • Regulatory NewsRegulatory News

    Researchers Link FDA Actions to Decrease in LABA Use in Asthma Treatment

    A recent study finds an association between regulatory actions by the US Food and Drug Administration (FDA) and the use of long-acting β2-agonists (LABA) commonly used to treat asthma. The study, published in the Journal of Allergy and Clinical Immunology in December, was conducted by a team of researchers at Kaiser Permanente, Harvard Medical School, Vanderbilt University and several FDA offices. In the study, the authors observed a slight, but statistically signific...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Offers New Pharmacovigilance Updates (17 December 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Releases More Pharmacovigilance Documents The European Medicines Agency (EMA) has released a batch of draft pharmacovigilance documents. EMA covers multiple aspects of good pharmacovigilance practice (GVP) in the texts, from changes to a template for direct healthcare professional (HCP) communication, to tweaks to a biologics-focused document. In total, EMA pub...
  • Regulatory NewsRegulatory News

    FDA Ban on CFCs in Asthma Inhalers Raised Costs for Patients, New Study Finds

    An environmental law which required the US Food and Drug Administration (FDA) to revoke the approval of products containing chlorofluorocarbons (CFCs) significantly raised the out-of-pocket expenses borne by patients with asthma, a new study published in the medical journal JAMA Internal Medicine . Background In 1987, the US signed an environmental agreement known as the  Montreal Protocol , an international agreement meant to preserve the ozone layer by phasing out ...
  • EMA Releases Draft Guidance on Development of Asthma Medications

    The European Medicines Agency (EMA) has released a new general guidance document on the development of medicinal products intended to treat asthma, a condition that restricts a patient's airways and can be fatal if improperly treated. Background and Overview The document, Draft note for guidance on clinical investigation of medicinal products for treatment of asthma , is meant to provide general advice on the development of asthma products, including clinical develop...
  • Environmental Regulations to Soon Force Two Asthma Products off Market

    A new missive to US consumers from the US Food and Drug Administration (FDA) warns them that, after a lengthy series of delays, they should prepare for the removal of the final two asthma inhalers containing chloroflurocarbon (CFC)-based propellants as of August 2013. Background The removal of the inhalers from the market has long been planned and has almost as long been a source of contention, particularly among some prominent legislators with authority over FDA. The ...
  • House Prepares to Bring Up Bill Allowing Sale of Banned Asthma Inhalers

    House legislators are preparing to bring up a piece of legislation that would allow the limited sale of a type of over-the-counter inhaler that was banned in 2012 as the result of environmental regulations. The bill, the Asthma Inhalers Relief Act of 2012 ( AIR Act ) would specifically apply to epinephrine-based asthma inhalers containing chlorofluorocarbons (CFCs)-a type of propellant used to discharge the epinephrine from the device. CFCs have technically been ba...
  • Blockbuster Asthma Drug Singulair Receives Generic Competition

    Generic versions of Merck's pharmaceutical blockbuster Singulair (montelukast sodium) are now available to consumers, making it the latest product to fall off the so-called 'patent cliff,' the US Food and Drug Administration (FDA) announced on 3 August . The drug is used by asthma and allergy sufferers to reduce inflammation, and was Merck's most lucrative, bringing in sales of up to $5 billion per year . The company is expected to lose much of its market share to its ...