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  • Regulatory NewsRegulatory News

    Device manufacturers warned by FDA for consumer complaint handling

    The US Food and Drug Administration (FDA) today released warning letters to two medical device manufacturers who, according to the agency, failed to address serious consumer complaints adequately. The agency also warned an India-based manufacturer of active pharmaceutical ingredients (API).     Luminex Corporation   Texas-based Luminex Corporation manufactures microsphere-based and PCR-based multiplexing systems; the firm was warned after a February 2020 inspec...
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    House proposes $3.2 billion for FDA in FY 2021

    On Monday, the US House Committee on Appropriations’ Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a markup session for fiscal year 2021 appropriations.   Of the total budget of $23.98 billion – a 2.3% increase from the prior fiscal year -- the bill allocates $3.212 billion for the Food and Drug Administration (FDA). This amount is an increase of $40.8 million over the prior fiscal year’s approximate $3.2 bill...
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    FDA clarifies informed consent provisions in COVID-19 clinical guidance

    The US Food and Drug Administration (FDA) last week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to clarify how sponsors can obtain informed consent from patients in isolation or who can receive electronic copies of informed consent documents but due to time constraints cannot print or electronically sign the documents.   The guidance , which has been updated frequently as more questions arise from sponsors during...
  • RoundupsRoundups

    Asia-Pacific Regulatory Roundup: TGA seeks data matrix code feedback

    Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on whether its proposed  standard for serialization and data matrix codes is clear and applies to the right medicines.   As it stands, Australia is yet to mandate serialization or the use of data matrix codes. However, with the European Union adopting data matrix codes and United States track-and-trace law specifying the use of similar two-dimensional codes, TGA has put forward a standard to ensure ...
  • ReconRecon

    Recon: Novavax, Regeneron get nearly $2B in Operation Warp Speed funding; FDA puts Cellectis CAR-T trial on hold after death

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna spars with US scientists over COVID-19 vaccine trials ( Reuters ) FDA warns of false positives with BD coronavirus diagnostic ( MedtechDive ) ( FDA ) US coronavirus response still crippled by lack of testing, Dr. Scott Gottlieb says ( CNBC ) Death in Cellectis off-the-shelf CAR-T trial triggers FDA hold ( Fierce ) ( STAT ) ( Endpoints ) US Will Pay $1...
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    EC details device assessment capacity amid COVID-19

    European notified bodies reported on their ability to conduct conformity assessment quickly for COVID-19-related medical devices and in vitro diagnostic medical devices, in response to a survey conducted by the European Commission (EC).   The survey sought to quantify lead times for conformity assessment for the various routes by which COVID-19-related medical devices may be placed on the market in the European Union (EU) and for which notified bodies need to be involv...
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    EMA, HMA consult on next 5-year network strategy

    The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) on Monday released their next five-year network strategy aimed at steering the regulators through a “time of rapid charge” for a two-month public consultation .   The 46-page European medicines agencies network strategy to 2025 sets out six priorities for the regulatory network in the post-coronavirus era and follows the agencies’ previous network strategy to 2020. (RELATED: EU regulators ...
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    FDA asks stakeholders to join PDUFA talks by 17 August

    The US Food and Drug Administration (FDA) on Monday called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Prescription Drug User Fee Act program by 17 August 2020.   The monthly periodic consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin the following month.   The call...
  • ReconRecon

    Recon: GSK, Sanofi in talks for £500M UK coronavirus vaccine deal; Regeneron begins Phase 2/3 trial for COVID-19 antibody cocktail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House teases executive orders on China, immigration and prescription drugs ( Politico ) Regeneron starts COVID-19 antibody cocktail late-stage trials, shares rise ( Reuters ) ( Press ) 2021 Health Plans Granted Leeway To Limit Consumers’ Benefit From Drug Coupons ( KHN ) FDA Commissioner Stephen Hahn won’t confirm Trump’s promises on vaccine timing ( ABC...
  • 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. The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19.   To date, three therapeutics are approved to treat COVID-19: dexamethasone in the  United Kingdom ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan .   Potential therapies are being...
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    Radiologists to FDA: Autonomous AI not ready for prime time

    Artificial intelligence is not ready for autonomy in radiology, according to two radiological professional associations who asked the US Food and Drug Administration (FDA) to wait for more rigorous testing and surveillance of the modality before authorizing its autonomous implementation in medical imaging.   In follow-up to a February 2020 workshop focused on artificial intelligence (AI) in medical imaging, the chairs of the American College of Radiology (ACR) and th...
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    RAPS' LatestRAPS' Latest

    Update: RAPS Convergence 2020 goes live online this September

    The RAPS Convergence conference will transition to a virtual-only experience for the first time ever in 2020, with two registration options for its upcoming annual event, which was originally planned to convene in San Antonio, TX. In addition, the event dates have been adjusted slightly to accommodate the new format and will take place 13–16 September. RAPS Convergence is the largest annual gathering of the global healthcare regulatory community and the only U.S. event e...