Lock Members Only close arrow-right cart search google-plus facebook twitter youtube flickr linkedin calendar user menu menu-close print share circle-down help briefcase latest recon star word-bubble news
RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.
Skip to Main Navigation Skip to Main Content Skip to Footer
8553b334-65f3-4a6c-bf5b-1d8fd1551c9a
Close Login

Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.

E-mail address & Password Combo is invalid
  • Forgot Password?
  • Create an Account
Close Search
Regulatory Affairs Professionals Society (RAPS)
  • menu_open
    Menu
  • TOPIC
  • search
    Open/Close Search
  • question_answer
    Community
  • school
    Learning Portal
  • calendar_today
    Calendar
  • Storefront
  • shopping_bag
    Marketplace
  • storefront
    Merchandise
  • My RAPS perm_contact_calendar
    Open/Close Sign In
  • Join
  • News
  • Membership
  • Education
  • Certification
  • Resources
News
    Regulatory Focus
    About RF
    RF Quarterly
    Subscribe
    Editorial Advisory Committee
    Submission & Guidelines
    Copyright & Terms
    Advertise
      Membership
        Join
        Renew
        Enterprise
        Welcome To RAPS
        Directory
        Chapters & Local Networks
        Fellows
        Get Involved
        Regulatory Exchange (RegEx)
        • 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
        Education
          Events
          Books
          Courses
          Learning Portal
          Corporate Training
          Convergence
          Euro Convergence
          Executive Development
          • Just released! Postmarket Requirements for Medical Devices: a Practical Guide

            This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.

            Buy the book
          Certification
            My RAC
            Apply
            Prep Tools
            Recertify
            Exam Sites & Scheduling
            About the RAC
            RAC Holders
            RAC Spotlights
            • RAC Spotlights

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

              LEARN MORE
            Resources
              Suppliers Guide
              About the Profession
              Careers
              Competency Framework
              Code of Ethics
              Scope of Practice
              Workforce Report
                Regulatory Focus™ > News Articles

                Narrow Results

                Today
                Today
                  • 1
                  • 2
                  • 3
                  • 4
                  • 5
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: FDA Approves Roche Hemophilia A Drug Hemlibra Ultragenyx Gets Priority Review Voucher With Enzyme Replacement Therapy Approval (16 November 2017)

                  • 16 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Billionaire founder of Insys to plead not guilty to opioid bribe scheme ( Reuters ) ( Forbes ) Old Habits Die Hard: Newer Diabetes Drugs Slow to be Adopted ( Medscape ) Powerful new cancer drugs are saving lives, but can also ignite diabetes or other autoimmune conditions ( Science ) Astellas faces US probe over patient assistance charity support ( Reuters ) F...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: AstraZeneca Bags Approvals for Fasenra, Faslodex Shanghai Pharma to Buy Cardinal's China Business for $557M (15 November 2017)

                  • 15 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Long-awaited study finds monthly Vivitrol as effective as daily pill for opioid addiction ( STAT ) ( Endpoints ) ( NYTimes ) ( NIH ) ( The Lancet ) AstraZeneca's scores FDA OK for a blockbuster severe asthma drug ( Endpoints ) ( Reuters ) ( PMLive ) ( Press ) FDA Approves AstraZeneca's Faslodex Combo for Advanced Breast Cancer ( Press ) FDA Clears First Device...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: FDA Approves Otsuka, Proteus' Digital Pill Janssen Drops Suit Against Samsung Bioepis' Remicade Biosimilar (14 November 2017)

                  • 14 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA approves digital pill that tracks when patients take it ( Reuters ) ( NYTimes ) ( WSJ ) ( STAT ) ( Press ) ( FDA ) Health officials lay out progress toward regulatory reform under Trump ( STAT ) Hospitals Sue to Block HHS From Slashing Lucrative Drug Subsidies ( WSJ ) Neurodegeneration upstart Denali outlines $100M IPO for its growing clinical work ( Endpoi...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: Gates Makes $100M Investment in Alzheimer's R&D J&J, Zymeworks Enter Potential $1B Discovery Pact (13 November 2017)

                  • 13 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Trump: Former Eli Lilly Exec to be Nominated as Next HHS Secretary ( Focus ) ( NYTimes ) ( Washington Post ) ( Politico ) ( The Hill ) ( Twitter ) Price investigation continues to roil HHS ( Politico ) Gates makes $100m personal investment to fight Alzheimer's ( Reuters ) ( Endpoints ) ( Financial Times ) ( Gates ) US Investments in Medical and Health Research ...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: FDA Approves Dynavax's Hep B Vaccine BMS' Sprycel Approved for Pediatric Ph+ CML (10 November 2017)

                  • 10 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Dynavax's hepatitis B vaccine gets FDA nod on third try, shares up ( Reuters ) ( Endpoints ) Deal would keep Pentagon out of product approvals ( Axios ) Former FDA Commissioners To Congress: Don't Give Pentagon The Power To Approve Drugs ( Politico ) Grading Gottlieb: How Attys View FDA Chief's First 6 Months ( Law360 -$) Heron takes on Merck's Emend with FDA ...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: Sage Shares Soar After Postpartum Depression Drug Meets Phase III Goals FDA Approves Merck Drug to Prevent Post-Stem Cell Transplant Infections (9 November 2017)

                  • 09 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Trump says he and China's Xi to try to end opioid crisis ( Reuters ) Despite Trump's Pleas, China's Online Opioid Bazaar Is Booming ( NYTimes ) The White House punted to Congress on opioids funding. Congress doesn't have a plan ( STAT ) FDA OKs Merck drug that prevents infection post-stem cell transplant ( Reuters ) ( Press ) ( Endpoints ) Sage Therapeutics sh...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: Ohio Drug Pricing Ballot Initiative Fails NICE Rejects Bayer's Stivarga for Liver Cancer (8 November 2017)

                  • 08 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA Commissioner Talks About His Tenure, Recruiting And LDTs ( Medtech Insight -$) Ohio's Drug Pricing Ballot Initiative Fails ( Cleveland ) ( STAT ) ( NYTimes ) Trump wants to cut Pharma's tax bill, but what are drugmakers actually paying? ( STAT ) House punts med device tax until after tax reform is finished ( MassDevice ) ( Washington Examiner ) FDA chief: ...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: FDA Approves Roche Drugs for Rare Blood and Lung Cancers Sen. Harris Questions Alkermes' Vivitrol Promotion Tactics (7 November 2017)

                  • 07 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Lawmakers defend 'unprecedented' Pentagon health panel, which could undermine FDA ( Politico ) ( Endpoints ) ( The Hill ) Mylan's EpiPen sales plummet as pricing scandal bites back ( Fierce ) Sen. Harris Investigates How Drugmaker Alkermes Pushed Its Opioid-Addiction Treatment ( Bloomberg ) ( Endpoints ) ( STAT ) ( The Hill ) FDA Approves Roche's Zelboraf to Tr...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: Valeant to Sell Sprout Back to Former Owners Novartis Submits Kymriah for EU Review (6 November 2017)

                  • 06 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Valeant to hand back maker of 'female Viagra' to former owners ( Financial Times ) ( Reuters ) ( Endpoints ) Earnings Preview: What To Expect From Valeant Pharmaceuticals On Tuesday ( Forbes ) Amgen is shaking up R&D (again), chopping 200 as Genentech targets 130 layoffs ( Endpoints ) CVS to offer nationwide next-day delivery in preemptive shot at Amazon ( USA ...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: FDA Approves Valeant's Glaucoma Drug Vyzulta Former GSK Head Witty to Lead UK Accelerated Access Scheme (3 November 2017)

                  • 03 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Valeant finally wins long-delayed FDA OK for its glaucoma drug, which is more good news for Aerie ( Endpoints ) ( Press ) Senators call for crackdown on pharmaceutical industry 'revolving door' ( Washington Post ) ( STAT ) GOP Tax Reform Bill Would Repeal Orphan Drug Research Credits ( Focus ) 7 ways biopharma would win — and lose — under the new tax bill ( STA...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: Teva Warns on Profit Outlook Hospitals Vow to Keep Medicare Drug Subsidies (2 November 2017)

                  • 02 November 2017
                  • By Zachary Brennan
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US CMS Finalizes Policies that Lower Out-of-Pocket Drug Costs and Increase Access to High-Quality Care ( CMS ) Hospitals Vow Fight to Keep Medicare Drug Subsidies ( WSJ -$) ( Modern Healthcare ) ( Politico ) Want Drug Regulators To Consider Real-World Evidence? Then Disrupt Their Outdated Regulatory Infrastructure ( Health Affairs ) FDA Panels Like Long-Ac...
                • Story Thumbnail
                  ReconReconRegulatory NewsRegulatory News

                  Regulatory Recon: Bayer, Novartis Fight With UK Doctors Over Avastin Use for AMD OPDP Enforcement Letters at Record Low (1 November 2017)

                  • 01 November 2017
                  • By Michael Mezher
                  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Pharma industry faces hypocrisy charge over patents ( Financial Times ) Pfizer expects broad interest for consumer health business ( Reuters ) FDA Panel Backs Indivior Opioid Addiction Drug ( Reuters ) ( Financial Times ) ( Endpoints ) OPDP Enforcement Letters at Record Low ( EyeOnFDA ) Innovating at the speed of the 21st century in pharmaceuticals ( McKinsey ...
                  • 1
                  • 2
                  • 3
                  • 4
                  • 5

                 

                 

                Regulatory Affairs Professionals Society (RAPS)
                5635 Fishers Lane, Suite 400
                Rockville, Maryland 20852

                P +1 301 770 2920 F +1 301 841 7956
                Email: raps@raps.org
                • ABOUT RAPS
                • GOVERNANCE
                • WORK FOR RAPS
                • PRESS ROOM
                • YEAR IN REVIEW
                • CELEBRATE THE PROFESSION
                • The Regulatory Profession
                • RAPS In Europe
                • Privacy Policy
                • TERMS OF USE
                • Advertise
                • FAQ
                • Code of Ethics
                • CALL FOR AUTHORS
                • Contact Us
                • Twitter
                • Facebook
                • LinkedIn
                • Google Plus
                • YouTube
                • InstagramInstagram

                © 2023
                Regulatory Affairs Professionals Society