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  • 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...
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    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...
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    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...
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    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...
  • ReconRecon

    Recon: FDA extends review of Novartis MS drug; South Korea approves remdesivir for emergency use

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA delays decision on Novartis’ potential blockbuster MS drug, wiping away priority review ( Endpoints ) ( Reuters ) Estimating a US price tag of $5K per course, remdesivir is set to make billions for Gilead, says key analyst ( Endpoints ) Novavax partners with contract drugmaker for COVID-19 vaccine manufacturing ( Reuters ) Moderna to begin pivotal phase 3 ...
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    European Commission consults on roadmap to pharmaceutical reforms

    The European Commission is looking to revamp parts of the regulatory framework for medicines in the EU to address shortages, access to medicines and innovation, according to a roadmap document released for consultation on Tuesday .   “There is a need to build a holistic, patient-centered, forward-looking EU Pharmaceutical Strategy which covers the whole life-cycle of pharmaceutical products from scientific discovery to authorization and patient access,” the Commission...
  • ReconRecon

    Recon: Pfizer to buy $500M of stock in smaller drugmakers; India approves remdesivir for emergency use

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Internal FDA Documents Show How Little Evidence The Agency Had Before Allowing Malaria Drugs To Be Used To Treat COVID-19 ( BuzzFeed ) Only 891 in Free HIV-Prevention Drug Program Meant for 200,000 ( Bloomberg ) Pfizer to invest up to $500 million in public drug developers ( Reuters ) ( STAT ) ( Endpoints ) White House Coronavirus Testing Czar To Stand Down ( ...
  • Regulatory NewsRegulatory News

    Hahn: FDA will make some changes amid COVID-19 permanent

    The US Food and Drug Administration (FDA) will look to permanently implement some of the processes and policies adopted in its response to the coronavirus disease (COVID-19) pandemic, FDA Commissioner Stephen Hahn said during a virtual briefing hosted by the Alliance for a Stronger FDA on Monday.   Hahn’s statements during the briefing closely mirrored statements he made in a pre-recorded video FDA uploaded to YouTube on Friday.   “As this pandemic has evolved, i...
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    EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

    In a response to officials at Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration, European Medicines Agency (EMA) Executive Director Guido Rasi said the agency is trying to figure out how to be transparent with regard to clinical trial data for products it reviews to treat or prevent coronavirus disease (COVID-19).   After spending years implanting its policy for proactively publishing clinical data for products submitt...
  • ReconRecon

    Recon: Emergent lands $628M contract to boost COVID-19 vaccine capacity; Congo declares new Ebola outbreak

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump announces US withdrawal from the World Health Organization ( Politico ) ( Reuters ) US awards new $628 million contract to boost output of potential COVID-19 vaccine ( Reuters ) Drugs standards group nixes plan to kick pharma's crab blood habit ( Reuters 1 , 2 ) ( The Guardian ) ( USP ) FDA approves Roche immunotherapy cocktail in liver cancer ( Reuters...
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    CHMP backs eight new medicines, waiting on remdesivir application

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending the authorization of eight new medicines, including a new vaccine against Ebola virus, and says it is waiting for Gilead Sciences to submit an application for conditional marketing authorization for remdesivir to treat coronavirus disease (COVID-19).   The update on the status of remdesivir comes nearly a month after the committee began a rolling review of the dr...
  • Regulatory NewsRegulatory News

    FDA looks to overhaul Orange Book, seeks input on patent listings

    Nearly 40 years after its creation, the US Food and Drug Administration (FDA) is looking to modernize its Orange Book , which lists patent, exclusivity and therapeutic equivalence information for approved drugs, as part of its effort to increase drug competition.   Specifically, FDA is seeking input on how the Orange Book is used and by whom, and on the types of patents that should  be submitted for listing in the book, such as those covering the device constituent ...