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  • Regulatory NewsRegulatory News

    French notified body GMED designated under MDR

    France’s GMED on Wednesday became the country’s first notified body designated under the Medical Devices Regulation (MDR) and the 15 th overall with less than a year before the regulation’s new date of application.   The Paris-based GMED is the sixth to be designated in 2020, following the designation of Swedish notified body Intertek in May. (RELATED: MDR delay official as industry calls to push back IVDR , Regulatory Focus 24 April 2020; Swedish notified bo...
  • Regulatory NewsRegulatory News

    NIH kicks off COVID-19 vaccine, monoclonal antibody research network

    The National Institutes of Health (NIH) today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the virus that causes infection with the novel coronavirus COVID-19.   The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS.   “Star...
  • Regulatory NewsRegulatory News

    More metformin recalled for NDMA; 6 firms now affected

    Two manufacturers have announced voluntary recalls of metformin formulations containing elevated levels of a potential carcinogen.   Granules Pharmaceuticals, based in Virginia, has issued a recall for its extended-release metformin, although just one of 12 batches tested exceeded acceptable levels of N-nitrosodimethylamine (NDMA) in the firm’s testing. The recall includes 100- and 500-count bottles of 750 mg metformin tablets.   Separately, India-based Lupin Pha...
  • RoundupsRoundups

    FDA Approvals Roundup: Rukobia, Byfavo, Inqovi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rukobia gets the green light for hard-to-treat HIV ViiV Healthcare’s Rukobia (fostemsavir) has been approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant infection whose current antiretroviral regimen is ineffective because of resistance, intolerance, or safety concerns.   The drug, a ...
  • ReconRecon

    Recon: EU reportedly strikes deals for Roche, Merck KGaA COVID drugs; Biogen submits aducanumab BLA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump administration submits formal notice of withdrawal from WHO ( STAT ) ( WSJ ) Pence, Azar reassure governors Trump won't end virus emergency declaration ( Politico ) Drug prices steadily rise amid pandemic, data shows ( Politico ) In a test for Hahn's FDA, Biogen submits controversial Alzheimer's drug aducanumab ( Fierce ) ( Endpoints ) ( BioPharmaDive ) ...
  • Regulatory NewsRegulatory News

    Unified agenda: FDA publishes lengthy to-do list

    Two final rules top the Spring 2020 regulatory agenda for the US Food and Drug Administration (FDA), addressing the importation of prescription drugs and the de novo classification process for medical devices. The agency’s unified agenda overall is mammoth and includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.   The importation of prescription drugs continues to be among deregulatory priorities for the Tr...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...