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  • Regulatory NewsRegulatory News

    FDA labeling study helps clear path for OTC naloxone

    Consumers reading a model drug facts label for naloxone could understand labeling sufficiently to use the opioid antagonist safely and effectively without the support of a healthcare provider, according to a label-comprehension study conducted by the US Food and Drug Administration (FDA).   The unusual move by the FDA could help clear a hurdle to approval of over-the-counter injectable and intranasal naloxone; many public health experts concerned about the impact of th...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months – if the process goes smoothly from conception to market availability.   This tracker lists COVID-19 vaccine candidates currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages o...
  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    The article discusses drug shortages in Germany the root causes of production problems with active pharmaceutical ingredients and drug product manufacturers. The authors offer analysis from a medium-sized generic drug manufacturer’s perspective. They offer a variety of reasons, all of which point to a “broken marketplace.” The article concludes with a discussion of mitigation activities and in an epilog address the current COVID-19 pandemic, warning that drugs and active i...
  • RoundupsRoundups

    EU Regulatory Roundup: MEB becomes a cornerstone of EMA assessments

    The Dutch Medicines Evaluation Board (MEB) has increased its share of European human rapporteur and co-rapporteur cases to become the dominant force in the centralized authorization procedure.   After Amsterdam was identified as the European Medicine Agency’s (EMA) next home, MEB began collaborating with regulators in other Member States to ensure work previously performed by the United Kingdom could be spread across multiple agencies. The initiative was intended to sp...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS unveils new 'Member Dashboard'

    RAPS has launched its brand new, online Member Dashboard , giving RAPS members one central place to view, access and manage their RAPS resources and member benefits. Once logged in, the dashboard displays your member profile and stored contact information, announcements, and key member resources, including webcasts, publications and other member-exclusive tools and content. As RAPS has continued to add to its menu of member benefits and other offerings, keeping track o...
  • ReconRecon

    Recon: FDA finds NDMA in some metformin products; EU plans permanent medical stockpile

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US “I’ll Send You the Contact”: Documents Expose FDA Commissioner’s Personal Interventions on Behalf of Trump’s Favorite Chloroquine Doctor ( Vanity Fair ) US coronavirus deaths top 100,000 as country reopens ( Reuters ) FDA Finds Carcinogen in Some Versions of Metformin ( Bloomberg ) ( Reuters ) ( STAT ) Pfizer ties up with glass maker Corning for vial supply ( ...
  • Regulatory NewsRegulatory News

    FDA explains impact of COVID-19 on applications, formal meetings

    The US Food and Drug Administration (FDA) on Tuesday issued immediately effective guidance explaining how the coronavirus disease (COVID-19) public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications.   The guidance features 11 questions and answers on how the agency intends to handle disruptions affecting meetings and goals under its user fee programs established by the Prescription Drug User Fee Act (P...
  • Regulatory NewsRegulatory News

    New approvals and indication from FDA: Alunbrig, VESIcare LC, Kynmobi and more

    This is the first in a series of weekly roundups of new drug approvals and indications from the US Food and Drug Administration (FDA).   Alunbrig gets new indication as first-line therapy for ALK-positive metastatic NSCLC On 22 May, FDA approved a new indication for Takeda’s Alunbrig (brigatinib) as a first-line treatment for adults with anaplastic lymphoma kinase‒positive metastatic non‒small cell lung cancer (NSCLC). The agency also approved a companion diagnost...
  • Regulatory NewsRegulatory News

    FDA warns South Korean firm for inadequate training, insufficient personnel monitoring

    A South Korean drug manufacturing firm was cited by the US Food and Drug Administration for having insufficiently trained personnel and for insufficient monitoring of aseptic processing areas.   The deficiencies were detected in an October 2019 FDA inspection of Samchundang Pharm’s Hwaseong facility. The agency found that Samchundang failed to establish the suitability of the sterility test method it used for final release of its drug products and also didn’t determi...
  • Regulatory NewsRegulatory News

    New York ophthalmic drugmaker cited for environmental and data integrity issues

    The US Food and Drug Administration (FDA) has warned a New York based pharmaceutical company for data falsification and failing to establish adequate monitoring in aseptic processing areas.   The firm, Altaire Pharmaceuticals, manufactures sterile ophthalmic drug products, as well as over the counter ophthalmic and homoeopathic products.   In its warning letter dated 12 March 2020, the FDA detailed findings from a 2019 inspection, where inspectors found that the ...
  • ReconRecon

    Recon: France, Italy and Belgium halt hydroxychloroquine use for COVID-19; Novavax buys Praha vaccines for $167M to boost capacity

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci: Hydroxychloroquine not effective against coronavirus ( Politico ) Moderna execs have cashed out $89M in shares this year, as stock soared on vaccine hopes ( STAT ) Trump administration to take action to cap insulin costs for seniors ( Washington Post ) ( STAT ) ( NPR ) Quest Diagnostics launches coronavirus testing for employees returning to work ( Reut...
  • Feature ArticlesFeature Articles

    Making the call to test in-house or outsource

    With dynamics across the medical device industry continuing to evolve, manufacturers should evaluate their current standing to ask themselves if they should perform in-house testing, outsource or a combination of both. This article discusses key considerations before making a final decision.   Introduction   Transitioning to the stringent requirements of the European Union Medical Devices Regulation ( EU MDR ) continues to pose significant hurdles for medical dev...