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  • Regulatory NewsRegulatory News

    Clinical Trials: FDA Releases Two Draft Guidances

    The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer treatment trials. Adaptive Trials The 32-page adaptive design draft guidance describes the principles for designing, conducting and reporting the results from an adaptive clinical trial. The draft also advises sponsors on the types of information FDA needs to evaluate the results from trials with adaptive designs,...
  • RAPS' LatestRAPS' Latest

    Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence

    • 28 September 2017
    US Food and Drug Administration Commissioner Scott Gottlieb addressed attendees of RAPS’ 2017 Regulatory Convergence on 11 September. He focused his remarks on making the clinical end of drug development more efficient and effective . If you missed it or would like to see his presentation again, the video is embedded below.
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Offers Technical Guidance on Clinical Trials (24 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Comprehensive Technical Guidance on Clinical Trials China Food and Drug Administration (CFDA) has released technical guidance on clinical trials, walking drug developers through the entire clinical research process, from preparing to run a first-in-human trial to designing post-marketing and pharmacogenomic studies. CFDA has created the document to provide ...
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    WTO Makes Permanent a Way to Help Poor Countries Gain Access to Generics via Compulsory Licenses

    The World Trade Organization (WTO) on Monday officially amended its Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement to allow developing countries facing public health problems and lacking the capacity to produce generic drugs the ability to obtain such medicines from third country producers under "compulsory licensing" arrangements.  The amendment, which is the first since TRIPS was created in 1995, provides a permanent legal basis for both poten...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Adopts Risk-Based Approach to Biologic Licenses (20 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Risk-Based Approach to Biologic Licenses, Ending Mandatory Inspections The Drug Controller General of India (DCGI) has scrapped the need for manufacturers to undergo a joint inspection before receiving certain biologics licenses. Instead of conducting pre-approval visits, Indian regulators will award Form 29 licenses within three days of receiving applications ...
  • Feature ArticlesFeature Articles

    Global Regulatory Strategy

    This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers. The term "strategy," per Merriam Webster (Edition 11), means "a careful plan or method for achi...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA to Discuss Future of Adaptive Pathways Program (15 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Schedules Workshop to Discuss Adaptive Pathway Program The European Medicines Agency (EMA) has scheduled a meeting to hear what drug developers and other groups have to say about its adaptive pathways program. EMA is presenting the workshop as an opportunity to discuss the lessons of the two-year pilot program and figure out the future of the staged approach to drug app...
  • Regulatory NewsRegulatory News

    Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices

    The United Nations (UN) High-Level Panel on Access to Medicines released its long-awaited report on Wednesday, with recommendations sure to rile up the pharmaceutical industry as it calls for World Trade Organization (WTO) members to no longer link the cost of research and development (R&D) with drug prices, as well as for an increase in the issuance of compulsory licenses and to require the disclosure of pharmaceutical R&D costs. The call for more compulsory license...
  • Regulatory NewsRegulatory News

    EMA to Continue Adaptive Pathways Program as Pilot Ends

    The European Medicines Agency (EMA) on Wednesday published a final report on its experience from its adaptive pathways pilot project, noting that a few aspects of the program need to be further improved and refined moving forward.  Though the vast majority of applications for the pilot were rejected, EMA said that moving forward, the agency needs to further integrate the patient voice into the program and refine the definition of methodologically sound strategies for col...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Adaptive Designs for Device Studies

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance that lays out how to design medical device clinical trials that allow for changes based on data, while maintaining study validity and integrity. FDA says it received 151 comments from seven entities , including the Advanced Medical Technology Association (AdvaMed) and AstraZeneca, on the draft guidance and “incorporated most of them in this final guidance.” Guidance Adaptive trial designs , first...
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    EMA Tries to Assuage Professors on Assumptions Linked to Adaptive Pathways Pilot

    The European Medicines Agency’s (EMA) Executive Director Guido Rasi and senior medical officer Hans-Georg Eichler sent a letter on Thursday to clarify some assumptions called into question by a group of nine professors who are criticizing aspects of the agency’s adaptive pathways pilot program. Background First announced in March 2014, EMA’s pilot program seeks to accelerate patient access to drugs for patients with pressing medical needs and after approval for a narrow...
  • Regulatory NewsRegulatory News

    NIH’s Exclusive Licenses to Biotech, Pharma Start-Ups: Lots of Secrecy, Few Successes

    It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the...