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  • 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...
  • Regulatory NewsRegulatory News

    FDA eases IRB review of COVID-19 expanded access requests

    Institutional review boards (IRBs) may establish procedures to have a single IRB member review individual patient expanded access requests for investigational drugs and biologic products to treat coronavirus disease (COVID-19), says new guidance from the US Food and Drug Administration (FDA).   The guidance provides clarification for IRBs that may be seeing increased numbers of individual patient expanded access requests related to COVID-19 infection.   In light ...
  • Regulatory NewsRegulatory News

    Antimicrobial approvals are not bottlenecked by FDA

    Sponsors seeking US Food and Drug Administration (FDA) approval for antimicrobial drugs accessed expedited clinical testing and review programs at least as frequently as those seeking approval of non-antimicrobials, according to a study published Tuesday in The Lancet Infectious Diseases . The median time from investigational new drug (IND) application to drug approval was shorter for antimicrobials than other drugs.   “We did not find evidence that antimicrobial de...
  • Regulatory NewsRegulatory News

    FDA approvals roundup: Tauvid, Oriahnn, Sirturo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tauvid nabs approval as first drug to aid imaging of tau pathology FDA has approved Avid Radiopharmaceuticals’ radioactive diagnostic agent Tauvid (flortaucipir F18 injection) as the first drug to image tau pathology, a distinctive characteristic of Alzheimer’s disease in the brain.   The drug is indicated for intravenous administration bef...
  • Regulatory NewsRegulatory News

    ICH updates on upcoming guidelines, adds new participants

    The International Council for Harmonisation (ICH) on Wednesday announced the addition of a new member and observer to its ranks and updated on the progress of guidelines in development following a virtual meeting of the ICH Assembly last week held in lieu of its previously scheduled meeting in Vancouver, Canada.   At the meeting, ICH welcomed Turkey’s Medicines and Medical Devices Agency (TITCK) as a regulatory member, after having joined ICH as an observer in 2018...
  • Regulatory NewsRegulatory News

    FDA issues 69 new and revised draft product-specific guidances

    The US Food and Drug Administration (FDA) on Wednesday released 26 new and 43 revised draft product-specific guidances to support the development of generic drugs.   The guidances , when finalized, are intended to promote generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, FDA has issued a total of 1,903 product-specific guidances.   The latest bat...