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

The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    Rituximab biosimilar prequalified by WHO

    The World Health Organization (WHO) has prequalified South Korean drugmaker Celltrion’s biosimilar version of rituximab, the second product achieving that status under a biosimilar prequalification pilot begun by the agency in 2018.   “Rituximab has revolutionized the treatment of diffuse large B-cell lymphoma, chronic lymphocytic leukemia and follicular lymphoma, significantly improving therapeutic responses, and remains a fundamental component of treatment regimens...
  • Feature ArticlesFeature Articles

    Integrating master files in the NDI notification process to facilitate innovation in dietary supplements

    This article discusses the application of master files to the new dietary ingredient notification process to protect intellectual property of ingredient manufacturers and incentivize submission of NDI notifications. The author describes an NDI master file model, based on the US drug master file, as a proposal for consideration by the US Food and Drug Administration.   Introduction Innovation grows industries, and it is no different for the dietary supplement industry...
  • Regulatory NewsRegulatory News

    European Commission updates on MDR, IVDR implementation timeline

    The European Commission this week updated its “rolling plan” for adopting implementing acts and other measures ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   The update follows the move to delay the implementation of MDR by one year due to the coronavirus disease (COVID-19) pandemic and the decision to delay Eudamed’s rollout by two years last December. (RELATED: MDR delay official as industry calls to push back IVDR , ...
  • Regulatory NewsRegulatory News

    PIC/S adopts cross-contamination, HBEL guides

    Following their adoption last month, two new Pharmaceutical Inspection Co-Operation Scheme (PIC/S) guidance documents entered into force this week, a questions and answers guidance on implementing risk-based prevention of cross-contamination and an aide-memoire on health-based exposure limit (HBEL) assessments.   Both documents were adopted on 22 May 2020 following development and review by the PIC/S Expert Circle and entered into force on 1 June 2020.   The firs...
  • ReconRecon

    Recon: GAVI raises $8.8B for immunization campaigns to 2025; AbbVie partners for COVID-19 antibody therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Wholesale drug prices — and net prices — keep falling for most drugs ( STAT ) Novavax gets US defense funding for its COVID-19 vaccine ( Reuters ) Inovio sues a key contract manufacturer as it races to develop a Covid-19 vaccine ( STAT ) ( Endpoints ) Melinta wins bidding war to land deal to acquire Tetraphase ( Fierce ) ( Endpoints ) Merck wins a third FDA n...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    As the COVID-19 pandemic continues, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. To date, just two therapeutics are approved to treat COVID-19: Avigan (favilavir) in  China , Italy and Russia, and Veklury (remdesivir) in  Japan . The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19 while the world waits for vaccine candidates to reach the market.   Potent...
  • Regulatory NewsRegulatory News

    FDA releases compliance program for CDER, CDRH-led combination product inspections

    In a newly issued compliance program , the US Food and Drug Administration (FDA) explains its approach to inspections of Center for Drug Evaluation and Research (CDER)- and Center for Devices and Radiological Health (CDRH)-led combination products.   The 46-page document lays out FDA’s intended implementation of the compliance program; inspectional operations and reporting considerations; sampling and analytical testing expectations; regulatory and administrative stra...
  • Regulatory NewsRegulatory News

    E-signatures clarified in FDA’s COVID-19 clinical trial guidance

    The US Food and Drug Administration (FDA) updated its guidance regarding informed consent for clinical trials during the coronavirus public health emergency to add information about electronic signatures for informed consent, and to provide clarification about remote assessments during clinical trials.   In its announcement regarding the updates, FDA said that it issued the guidance “because we recognize that the COVID-19 public health emergency may impact the conduc...
  • 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...
  • ReconRecon

    Recon: EU to use €2.4B emergency fund for coronavirus vaccines; Roche test for severe COVID-19 gets EUA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA struggles to remain independent amid race for virus cure ( Politico ) Roche Test for Severe Covid-19 Gets Emergency FDA Approval ( Bloomberg ) ( Reuters ) Trump Administration Selects Five Coronavirus Vaccine Candidates as Finalists ( NYTimes ) ( Endpoints ) Malaria Drug Promoted by Trump Did Not Prevent Covid Infections, Study Finds ( NYTimes ) Gilead bo...
  • RoundupsRoundups

    EU Regulatory Roundup: Regulators to prioritize COVID-19 procedures if needed

    COVID-19 procedures will be prioritized if members of the European Medicines Regulatory Network (EMRN) cannot execute all activities, according to a business continuity plan developed by the European Medicines Agency (EMA) and the European Commission (EC).   The extent of capacity constraints defines the plan three-phase plan. In the first phase, members of EMRN can fulfill routine regulatory tasks for medicines authorized centrally and nationally. The third phase kicks...
  • Regulatory NewsRegulatory News

    FDA defends its oversight of foreign drugs amid Senate, GAO criticism

    During a Senate Committee on Finance hearing Tuesday, officials from the US Food and Drug Administration (FDA) responded to criticism from senators and a new report from the Government Accountability Office (GAO) on its oversight of foreign drug manufacturers.   The hearing follows FDA’s move to halt most foreign inspections in March as a result of the coronavirus disease (COVID-19) pandemic. (RELATED: Coronavirus prompts FDA to cancel travel, postpone inspection...