• Feature ArticlesFeature Articles

    Foods for special medical purposes/medical foods: A global regulatory synopsis

    This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions – EU, UK, US, China, and other regions of the world – to improve the role of nutrition in support of optimal care for patients. Part 1 covers general principles governing FSMPs, use of FSMPs in community and hospital settings, common regulatory challenges, opportunities for category growth, and considers a multistakeholder initi...
  • RF Quarterly

    Elements of global regulatory strategy — The basics

    For most of regulatory science’s established history, regulations governing drug safety and efficacy were established on a country-by-country basis. For instance, a US-centric framework was appropriate when most US-manufactured drugs were distributed and sold largely on the US market. Today, the pharmaceutical industry’s expanding global reach means drug distribution is multinational, yet the current regulatory frameworks still are largely national or regional in focus. Th...
  • RF Quarterly

    An introduction to regulatory strategy

    In its simplest form, strategy can be considered bringing a new product to market, but it touches every product development lifecycle aspect and can ensure market sustainability. A limited or inadequate strategy can challenge global expansion, thus emphasizing the importance of a well-designed and executed regulatory strategy. This article identifies the requirements for developing a strategy for a drug development plan, as well as postmarketing strategy, with some global ...
  • ReconRecon

    Recon: US buys another 200M doses of Moderna vaccine; First patient receives Biogen Alzheimer's drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US buys 200 mln more Moderna COVID-19 vaccine doses ( Reuters ) First patient receives controversial Biogen Alzheimer's drug ( Reuters ) Regeneron’s antibody therapy cuts deaths among some hospitalised COVID-19 patients -study ( Reuters ) ( STAT ) US authorizes another 14 mln doses of Johnson & Johnson's COVID-19 vaccine -sources ( Reuters ) Lawmakers revive ...
  • ReconRecon

    Recon: AZ antibody cocktail fails to prevent COVID symptoms in large trial; Former FDA Commissioner Hahn ventures on to Flagship

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax says efficacy preserved in participants receiving influenza, COVID-19 vaccines ( Reuters ) Trump’s FDA commissioner takes job at Moderna backer ( Washington Post ) ( Endpoints ) Divisive Drug Patent Proposal From Trump Era Is on Biden Agenda ( Bloomberg ) ( Law360 ) Sage's depression drug study results show improvement in symptoms ( Reuters ) ( STAT ) ...
  • ReconRecon

    Recon: FDA asked J&J to discard 60M vaccine doses made at Emergent plant; EMA adds rare blood condition as side effect of AZ shot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA tells J&J that 60M doses made at Emergent plant cannot be used ( NYTimes ) ( Reuters ) ( Politico ) J&J vaccine doses to be released, but many will be tossed ( AP ) ( Axios ) ( FDA ) FDA faces mounting criticism over Alzheimer’s drug approval ( Reuters ) Eli Lilly memo says firm did not make false statements to FDA ( Reuters ) Controversial drug approval ...
  • ReconRecon

    Recon: FDA extends shelf life of J&J vaccine; Ocugen to seek BLA for its COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to donate 500 million Pfizer doses to poor nations ( Reuters ) ( Politico ) US is in discussions with Moderna on buying Covid vaccine doses for other nations ( CNBC ) Moderna files for US authorization to use its COVID-19 vaccine in teens ( Reuters ) ( NYTimes ) FDA extends shelf life of Johnson & Johnson COVID-19 vaccine ( Reuters ) Ocugen to file for ful...
  • ReconRecon

    Recon: US signs for $1.7M courses of Merck’s experimental COVID drug; FDA approves Vertex CF drug for 6-11 year olds

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says he will be announcing a vaccine plan for the world ( Reuters ) White House urges states to seek longer shelf life for J&J shots as millions near expiration ( Reuters ) ( KHN ) ( Politico ) US signs $1.2 bln deal for 1.7 mln courses of Merck's experimental COVID-19 drug ( Reuters ) ( HHS ) Vertex cystic fibrosis treatment gets U.S. approval for use i...
  • ReconRecon

    Recon: Pfizer to start large pediatric trial of COVID-19 vaccine; FDA pushes back decision on Incyte’s Jakafi

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer to start large study to test COVID-19 vaccine in children below 12 ( Reuters ) Inovio expands partnership with Advaccine for COVID-19 vaccine study ( Reuters ) Incyte the latest to fall victim to JAK scrutiny as FDA pushes back Jakafi review in GVHD ( Fierce ) FDA rejects Google's push to add virtual exam for Parkinson’s disease to its smartwatch ( Endp...
  • ReconRecon

    Recon: Biogen wins accelerated approval for aducanumab; FDA lifts hold on bluebird bio gene therapy trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works ( NYTimes ) ( Politico ) ( STAT ) ( FDA 1 , 2 ) Why Biogen may be sitting on the most lucrative product in pharmaceutical history ( STAT ) FDA approves drug to treat smallpox ( FDA ) J&J vaccine drive stalls out in US after safety pause ( Reuters ) FDA approves Novo Nordisk's semagluti...
  • ReconRecon

    Recon: UK authorizes Pfizer-BioNTech vaccine for adolescents ages 12-15; News from ASCO

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US authorizes lower dose of Regeneron's COVID-19 antibody therapy ( Reuters ) ( Endpoints ) Investors, patients await FDA decision on Biogen Alzheimer's drug due Monday ( Reuters ) Biden health official 'taking a look' at Trump drug pricing proposal ( The Hill ) First US Vaccine Donations Will Go to ‘Wide Range’ of Nations in Need ( NYTimes ) For first time, ...
  • ReconRecon

    Recon: Senate finance chair probes AbbVie over corporate tax strategy; Abernethy goes to Verily to head clinical research

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden admin probes risk of low-level contamination in vaccines made at troubled plant ( Politico ) Ejected from a troubled plant, AstraZeneca is in talks about producing vaccine for US government at another site. ( NYTimes ) ( Reuters ) Lawsuit says Bristol-Myers avoided $6.4 bln payment by delaying cancer drug ( Reuters ) As FDA decides on Biogen drug for Alz...