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Who We Are
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    Advancing the Profession
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  • About the Regulatory Profession

    The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

    Learn More About Regulatory
News & Articles
    Regulatory Focus™
    About Regulatory Focus
    Subscribe to RF Today
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    Editorial Advisory Committee
    Copyright & Terms of Use
    Feature Articles
    Regulatory Recon
    Regulatory Explainers
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  • Submit an Article

    Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.

    LEARN MORE
Membership
    Join RAPS
    Renew Your Membership
    Member Dashboard
    Member Directory
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    Chapters & Local Networks
    Get Involved
    Enterprise Membership
    RegEx Community App
    Volunteer Opportunities
    RAPS Fellows
    Awards
  • Regulatory Code of Ethics

    One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

    Follow the Code
  • Member Knowledge Center

    Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.

    Get Started
Careers
    Careers
    Find a Job
    Post a Job
    About the Regulatory Profession
    Onboarding Essentials
    RAC Credential
    Scope of Practice Survey
    Career Fairs
    RegEx Career Community
    Regulatory Competency Framework
  • Regulatory Competency Framework

    Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

    LEARN MORE
Education & Events
    Education & Events
    E-Learning
    In-Person
    European Events
    Calendar
    RAPS Convergence
    Learning Portal
    Executive Development
    RAC Prep
    Online Workshops
    Custom Corporate Training
    RAPS Euro Convergence
  • RAPS Euro Convergence 2021

    RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.

    LEARN MORE
  • RAPS Convergence 2021

    Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.

    LEARN MORE
Publications & Resources
    Publications & Resources
    Books
    Fundamentals Series
    Regipedia
    Podcasts
    University Resources
    Suppliers Guide
    University Degrees & Certificates
    Publication Groups Rates
    Call for Authors
  • Just Released: Regulatory Intelligence 101, Third Edition

    With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.

    ORDER YOURS
  • Regipedia

    Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.

    Get involved
RAC Credential
    RAC Credential
    RAC Spotlights
    Apply
    Prepare for the Exam
    Exam Sites & Scheduling
    RAC Benefits
    RAC or Certificate Training
    RAC Resources
    Maintain your RAC
    Current RAC Holders
  • NEW! RAC Spotlights

    Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.

    LEARN MORE

Regulatory Focus

Regulatory Focus™ > News Articles

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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Government Shutdown Looms First PARP Inhibitor Approved in Japan (19 January 2018)

    • 19 January 2018
    • By Zachary Brennan 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Showdown Looms as Senate Democrats Prepare to Reject Spending Bill ( WSJ -$) ( Politico ) House passes stopgap bill that would delay medical device tax; Senate Dems vow filibuster ( MassDevice ) ( MedPage Today ) ( Stat ) No One’s Interests Would Be Served by a Shutdown ( Alliance for a Stronger FDA ) The FDA Budget FY 18: Where Does the Money Come From?...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Kite Teams Up With Pfizer on Lymphoma Combo Fed Up With Drugmakers, Hospitals Start Their Own (18 January 2018)

    • 18 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US US Doctors Plan to Treat Cancer Patients Using CRISPR ( MIT Technology Review ) Gilead's Kite Teams up With Pfizer on a Lymphoma Combo ( Endpoints ) ( Press ) Fed Up With Drug Companies, Hospitals Decide to Start Their Own ( NYTimes ) ( STAT ) How a government shutdown could affect drug safety, flu response, and more ( STAT ) Senate committee advances Azar nom...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Celgene in Talks to Buy Juno Chinese Investors Eye J&J's Diabetes Business (17 January 2018)

    • 17 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Celgene in discussions to buy Juno Therapeutics ( Financial Times ) ( CNBC ) FDA and Pentagon Forge Breakthrough Designation Agreement ( Focus ) ( Reuters ) ( FDA ) FDA expects IV fluid shortage to improve in coming weeks, months ( Reuters ) ( FDA ) Is Juno worth a $10B-$12B buyout price? Analysts see megabucks deal in the making on reported Celgene talks ( End...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Merck's Keytruda Combo Extends Survival in Lung Cancer Trial Sandoz Files Humira Biosimilar for US Approval (16 January 2018)

    • 16 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Room for another: Sandoz files Humira biosimilar in US ( BioPharmaReporter ) ( PMLive ) ( Press ) Eiger to abandon blood pressure drug after trial failure ( Reuters ) ( Endpoints ) ( Press ) Big Pharma efforts on Alzheimer's tested by Pfizer exit ( Financial Times ) Transparency: FDA to Release Portions of Redacted Clinical Study Reports ( Focus ) ( STAT ) Op ...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Google Backs UK Universal Vaccine Company Shire Wins EU Approval for Long Acting Hemophilia A Treatment (15 January 2018)

    • 15 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Gene Therapy Could Make Cancer Care More Unequal, and This Map Shows Why ( MIT Technology Review ) States require doctors to use prescription drug monitoring systems for patients ( Washington Post ) FDA Delays Implementing Parts of 'Intended Use' Rule ( Focus ) ( STAT ) ( Pink Sheet -$) ( Law360 -$) Billionaire-owned Hearing Aid Manufacturer's Former Executives...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: FDA Approves AZ's Lynparza to Treat Breast Cancer with BRCA Mutation Roche's MS Drug Ocrevus Wins EU Approval (12 January 2018)

    • 12 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US In a pioneering first, AstraZeneca scores FDA OK to use its PARP against breast cancer ( Endpoints ) ( Reuters ) ( GenomeWeb ) ( FDA ) Trump expects medical exam to go well Friday ( Reuters ) Drugmakers see a pricing blueprint in an $850,000 gene therapy ( Reuters ) Wait, It Costs How Much? Biotech Balances Optimism, Uncertainty For 2018 ( Forbes ) Gene therap...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: FDA Panel Votes Against Testosterone Therapies Endo Subpoenaed for Opioid Information (11 January 2018)

    • 11 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US The FDA still hates low T drugs — experts bat back a pair of contenders ( Endpoints ) ( Medpage ) ( Fierce ) ( Lipocine ) Endo subpoenaed for information on opioid painkillers ( Reuters ) ( WSJ ) An 'unsustainable' model: Drug makers signal interest in exiting vaccine development during crises ( STAT ) JPM18 Day 3: Valeant and Acorda make plans, promises of M&A...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Bluebird Planning for First Three Approvals by 2019 EU Approves Vertex' Orkambi for Younger Patients (10 January 2018)

    • 10 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Bayer, J&J win reversal of $28 million verdict in Xarelto lawsuit ( Reuters ) HHS Secretary Nominee: 'No Silver Bullet' to Bring Down Drug Prices ( Focus ) ( NYTimes ) ( STAT ) ( Fierce ) ( Axios ) Bluebird to seek approvals for three treatments by end of 2019 ( Reuters ) ( Endpoints ) Trial Transparency: NIH Says Final Rule From 2017 has Helped ( Focus ) Face...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Lilly CEO Says Tax Reform May Boost Pharma Deal Making 50 Top Managers Replaced at GSK in Walmsley's 1st Year (9 January 2018)

    • 09 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Eli Lilly CEO Says Tax Reform May Lead to More Successful Deals ( Bloomberg ) ( CNBC ) Drug Industry Isn't Giving Up on Alzheimer's ( WSJ ) The Winners And Losers Of JP Morgan Monday ( Forbes ) Axovant: That positive p-value we reported yesterday? Um, we screwed that up too ( Endpoints ) Pfizer program seeks closer ties with top universities ( Fierce ) ( Press...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Celgene to Buy Impact Biomedicines for Up to $7B Ablynx Rejects Novo's $3.1B Bid (8 January 2018)

    • 08 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US $11 billion biotech binge fuels forecasts of 2018 M&A surge ( Reuters ) ( Boston Globe ) Celgene to Buy Impact Biomedicines ( WSJ ) ( STAT ) ( Endpoints ) ( Fierce ) ( Financial Times ) ( Press ) Good morning from JPM ( Politico ) ( STAT ) JPM is like a biotech dating game, just ask these questions before hooking up ( STAT ) Axovant shares blasted as premier ...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: FDA Expands Use of Amgen's Fracture Prevention Drug Xgeva Takeda Signs Alzheimer's Pact With Denali, Strikes Deal to Acquire TiGenix (5 January 2018)

    • 05 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Drug Industry Is Ripe for a Wave of Deals ( WSJ ) FDA expands use of Amgen's blockbuster drug ( Reuters ) Look out, Teva: Mylan's Copaxone copy has already captured serious share ( Fierce ) Johnson & Johnson pens Alzheimer's gene therapy pact ( Fierce ) ( Endpoints ) Kala Pharma shares damaged by mixed data from PhIII dry eye program ( Endpoints ) ( Press ) C...
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    ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Pfizer Signs $830M Discovery Pact with Arvinas Philippines Fines Sanofi, Pulls Dengvaxia Registration (4 January 2018)

    • 04 January 2018
    • By Michael Mezher 
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Pfizer lines up an $830M alliance with Arvinas on protein degradation ( Endpoints ) ( Fierce ) ( Pharmafile ) ( Press ) Drug Policy: The Year In Review, And The Year Ahead ( Health Affairs ) Momenta, Mylan plan trial of biosimilar to Regeneron eye drug ( Reuters ) FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics ( Focus ) Allergan to cut mo...
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