RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Euro Convergence: Navigating changing regulation of drug-device combination products

    As European regulators prepare to implement new requirements for drug-device combination products under the upcoming Medical Device Regulation (MDR), manufacturers and notified bodies are grappling with some of the lingering questions. “There are still some gaps… and some areas where we’d like to see more certainty, but until then we will continue to keep the dialogue going,” Jonathan Sutch, PhD, senior medicinal specialist at the notified body BSI Group, said during a ...
  • Regulatory NewsRegulatory News

    EMA rolls out implementation plan to address nitrosamine impurities

    The European Medicines Agency (EMA) has rolled out its full plan to implement recommendations to reduce the risk that medicines will be contaminated with nitrosamine impurities, identifying short-, medium- and long-range priorities. The agency has also made templates available for marketing authorization holders to perform risk assessment and confirmatory testing.   The implementation plan builds out a framework for putting in place the specific recommendations of a ...
  • Regulatory NewsRegulatory News

    EMA highlights multiple considerations when developing drugs for older adults

    In a recently released reflection paper, the European Medicines Agency (EMA) urged pharmaceutical manufacturers to consider the physical and cognitive abilities of patients age 65 years and older when developing products. Those considerations may impact everything from the dosage form to the package labeling. But the sole focus should not be on chronological age since patients of any age may experience similar needs or impairments. “For example, the need for an easy to ...
  • Regulatory NewsRegulatory News

    With new guidance, FDA moves toward uniform postmarketing reporting

    A new draft guidance related to postmarketing requirements and commitments is available from the US Food and Drug Administration (FDA). The document details how drug and biologics marketers will use two forms for online submission of annual status report and other required postmarketing information.   The forms, FDA 3988 and 3989, are the mechanisms by which applicants will fulfill requirements for annual reporting on the status of postmarketing requirements (PMRs) and...
  • Regulatory NewsRegulatory News

    CHMP: Test all metformin for nitrosamines before release

    Medicines containing the diabetes medication metformin must be tested for the presence of nitrosamines before being released into the European market, said a committee of the European Medicines Agency (EMA) following its scheduled September meeting.   “As of October 2020, EMA and the national competent authorities are asking marketing authorization holders for metformin-containing medicines to test their medicines before releasing them onto the market,” said EMA’s Comm...
  • ReconRecon

    Recon: New healthcare investing record; Sanofi slim-down, sell-off?

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cuomo: Public should be 'very skeptical' about COVID-19 vaccine ( The Hill ) Dr. Scott Gottlieb: U.S. in 7th inning of the pandemic but the ‘hardest part’ is likely ahead ( CNBC ) For Trump, Covid-19 therapeutics are the new vaccines ( STAT ) Whatever happened to Deborah Birx? ( The Hill ) What about the German negotiation model? Biden steers ...
  • RoundupsRoundups

    FDA Approvals Roundup: New formulation for Ultomiris

    New formulation Ultomiris gets new formulation for blood-related disorders  Alexion’s Ultomiris (ravulizumab-cwvz injection) has been  approved  as a 100 mg/mL formulation for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (aHUS) for adults and children aged one month or older.  The  new  formulation of the complement inhibitor will cut annual infusion time by about 60%, or six hours, compared with the 10 m...
  • RoundupsRoundups

    Asia-Pacific Roundup: Japan’s PMDA shares principles for evaluation of COVID-19 vaccines

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published principles for evaluating COVID-19 vaccines. The principles echo guidelines published in other parts of the world, for example by recommending that studies are designed to show vaccines prevent COVID-19.   PMDA, like its peers, is against the use of surrogate measures given the lack of evidence linking them to the key endpoint of COVID-19 prevention. Clinical trials to assess the preventive effect ...
  • Regulatory NewsRegulatory News

    Good real-world outcomes for generic levothyroxine, despite narrow therapeutic index

    Generic versions of levothyroxine – a treatment for hypothyroidism -- are just as effective in restoring thyroid stimulating hormone levels as brand-name drugs in a real-world population, according to a recent study conducted by researchers from the US Food and Drug Administration, Yale University, and the Mayo Clinic.   Generic levothyroxine is prescribed about six-to-one over branded levothyroxine, but that still leaves generic prescriptions lagging behind prescrib...
  • Regulatory NewsRegulatory News

    EMA moves to IRIS for scientific advice questions

    The European Medicines Agency (EMA) is transitioning to an online platform for drug developers to use when requesting scientific advice. The change will become effective on 19 October for developers of both human and veterinary medicinal products.   The regulatory and scientific information management platform, known as IRIS , “aims to make the handling of product-related regulatory procedures more efficient and user-friendly and to ensure better data quality through ...
  • Regulatory NewsRegulatory News

    FDA seeks withdrawal of Makena, generics from market

    The US Food and Drug Administration (FDA) on Monday proposed to withdraw Amag Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate injection) and its generics from the market after a postmarket study failed to confirm clinical benefit.   The request comes nearly a year after FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee recommended that the agency withdraw its approval for the drug and more than nine years after it received accelera...
  • Regulatory NewsRegulatory News

    Misleading ads for asthma, weight loss meds garner warning letters

    Emails from an executive and sales staff falsely touted an inhaled steroid preparation as a treatment for COVID-19, prompting a warning from the branch of the US Food and Drug Administration (FDA) that oversees drug promotion. This communication, together with one directed to the application holder of a weight loss medication, made the third and fourth warning letters of the year issued by FDA's Office of Prescription Drug Promotion (OPDP).    In a 24 September let...