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  • Feature ArticlesFeature Articles

    Emergency use authorizations for IVDs: Building on lessons learned

    Emergency use authorization (EUA) is a tool used by the US Food and Drug Administration (FDA) for providing quick access to unapproved medical products in response to a public health emergency. In vitro diagnostics (IVDs) have been critical EUA products in past emergencies and have proven equally important during the COVID-19 pandemic. For regulatory professionals, the valuable lessons learned from EUA policy and ensuing changes over time have provided a crucial foundation...
  • Feature ArticlesFeature Articles

    Regulatory pathways for innovative medicinal products for Switzerland

    Switzerland is not part of the EU or the European Economic Area (EEA), therefore, a national marketing authorization application (MAA) for Switzerland must be filed and approved before a medicinal product can be placed on the Swiss market. Besides the standard MAA procedure, there are expedited, simplified, and work-sharing procedures that can be selected, depending on the product characteristics. This article provides an overview of relevant Swiss marketing authorization ...
  • Feature ArticlesFeature Articles

    The changing regulatory landscape for laboratory developed tests

    The COVID-19 pandemic has highlighted the importance of reliable and accurate diagnostic tests. Laboratory developed tests (LDTs) do not typically require premarket review. The US Food and Drug Administration (FDA) has repeatedly proposed more rigorous regulatory frameworks for LDTs but has been unsuccessful owing to concerns about the impact on test availability and innovation. In this article, the authors describe the existing regulations and consider both sides of the d...
  • Feature ArticlesFeature Articles

    Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers

    This article examines regulatory considerations for emergency use authorizations for medical device manufacturers in response to the COVID-19 pandemic. The authors summarize the four phases of issuance as:  phase 1 ‒ in vitro diagnostic products; phase 2 ‒ personal protective equipment; phase 3 ‒ ventilators and components; and phase 4 ‒ other relevant medical devices. They emphasize the EUA is subject to statutory limits tied to the end of the public health emergency and ...
  • Regulatory NewsRegulatory News

    Do Biopharma Companies Really Spend More on Marketing Than R&D?

    As the drug pricing debate on Capitol Hill continues, the debate over how biopharma companies spend also continues. From 2014 through 2016, various publications—from the Washington Post to Vox to MedCity News —published an eye-opening chart showing that nine of the top 10 large pharmaceutical companies (all but Roche) spent more on marketing than research and development (R&D). The source of the chart is a 2014 BBC article , which relied on GlobalData, to...
  • Regulatory NewsRegulatory News

    Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation

    A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the US Food and Drug Administration (FDA) to revoke the orphan designation granted to Indivior’s opioid use disorder treatment Sublocade (buprenorphine extended-release injection).   “Sublocade is not now, nor was it ever a bona fide orphan drug, particularly since more than two million Americans currently are afflicted by opioid addiction,” the pe...
  • Regulatory NewsRegulatory News

    Marketing Status Notifications: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Wednesday unveiled new draft guidance to help sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they’re now required to share with FDA on the marketing status of their brand and generic drugs. Thanks to the FDA Reauthorization Act of 2017 , drugmakers are required to provide additional information regarding the marketing status of approved drug products, includ...
  • Regulatory NewsRegulatory News

    One-Time Marketing Status Reports Due in February, FDA Says

    The US Food and Drug Administration (FDA) is calling on all new drug application (NDA) and abbreviated new drug application (ANDA) holders to submit one-time written reports on whether their products are available for sale or if they have been withdrawn or were never made available for sale. Reports are due 14 February and are required under a provision from the law reauthorizing the user fee programs. "The NDA or ANDA holder can submit the one-time report to FDA ...
  • Feature ArticlesFeature Articles

    Marketing Exclusivity for Over-the-Counter Switched Products

    This article discusses the regulatory process for changing a drug's status from "prescription only" to Over-the-Counter (OTC) and discusses issues related to gaining exclusivity for OTC switched products under FDA regulations and guidance and Congressional legislation. Introduction Prior to the enactment in 1951 of the Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) , a pharmaceutical manufacturer could decide whether to market a product...
  • Regulatory NewsRegulatory News

    Medtronic Settles Deceptive Advertising Lawsuit for $12M

    State attorneys general in Massachusetts, Oregon, California, Illinois and Washington on Wednesday announced a $12 million multi-state settlement with Medtronic to resolve claims the company deceptively marketed one of its devices known as Infuse. The complaint alleged that Medtronic used deceptive company-sponsored scientific literature to convey false and misleading claims about the device’s safety, comparative efficacy and superiority to expand its market. Spec...
  • Regulatory NewsRegulatory News

    Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted

    The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies. The report found that the majority of post-marketing requirements (PMRs) and post-marketing commitments (PMCs) are progressing on schedule, though of those studies that are open (734 NDAs and 156 BLAs are open as of 30 September 2016) and on-schedule, few PMRs for new drug applications ...
  • Regulatory NewsRegulatory News

    House, Senate Pass Compromise Bill on FDA, DoD Emergency Use Authorizations

    The US Senate and House of Representatives this week passed a bill forging a compromise over a controversial provision in the National Defense Authorization Act for Fiscal Year 2018 ( NDAA ) that would have allowed the Department of Defense (DoD) to authorize the use of medical products on an emergency basis. The bill is partly the result of criticism raised over the US Food and Drug Administration’s (FDA) sluggishness in approving a French freeze-dried plasma pr...