• Regulatory NewsRegulatory News

    CDSCO Advances Draft Medical Device Rules, Outlines Fees

    India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders. In June, India announced it was abandoning its plan to amend the Drugs and Cosmetics Act of 1940 in favor of developing new, separate legislation for the regulation of drugs and medical devices. Shortly afterwards, CDSCO released preliminary draft rules est...
  • Regulatory NewsRegulatory News

    ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning

    Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ISO 13485:2016 as soon as possible. Trautman, who left her position as associate director for international affairs at FDA's Center for Devices and Radiological Health (CDRH) for a position at NSF International earlier this year, was instrumental in writing FDA's 1996 Quality...
  • RAPSRAPS' Latest

    Regulatory Convergence Preview: Regulation and Innovation

    RAPS will bring the largest annual gathering of the global healthcare regulatory profession to San Jose, CA, 17–20 September . The 2016 Regulatory Convergence will take place at the San Jose McEnery Convention Center. The Convergence is expected to draw more than 2,000 participants, including healthcare product regulators, scientists, researchers and regulatory professionals from life sciences companies. This year marks RAPS’ 40th anniversary, and the Converg...
  • RAPSRAPS' Latest

    RAPS' Scope of Practice Survey Shows Regulatory Pros Play Increasingly Strategic Role Compensation Up

    RAPS today released the results of its biennial survey of healthcare product regulatory professionals around the world. The survey asked respondents about their daily work, education and professional backgrounds, and compensation. RAPS has compiled and published key survey results and analysis in its 2016 Scope of Practice & Compensation Report for the Regulatory Profession , which can be downloaded at www.RAPS.org/sop . Among the most significant findings, r...
  • RAPSRAPS' Latest

    Prepare for the Digital Revolution, Says Convergence Keynote Speaker Ray Wang

    When the 2016 Regulatory Convergence begins next month in San Jose, R “Ray” Wang , principal analyst, founder, and chairman of Silicon Valley-based Constellation Research, will kick things off Sunday evening, 18 September, with opening keynote remarks. Wang is a noted Silicon Valley strategic thinker with expertise in areas including technology and innovation, digital disruption, business model design, engagement strategies and customer experience. He also starte...
  • Regulatory NewsRegulatory News

    The Next PDUFA: New Performance and Procedural Goals

    Exactly one year after the first round of negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA), the US Food and Drug Administration (FDA) on Friday released the full details of the performance and procedural goals for fiscal years 2018 through 2022. The 46-page document, which outlines how the agency will use the user fees provided to it from industry, breaks down not only the planned deadlines for new guidance documents and pilot projec...
  • RAPSRAPS' Latest

    RAPS Members on the Value of Regulatory Convergence

    RAPS’ Regulatory Convergence is the world’s largest annual gathering for the healthcare product regulatory profession, and this year will be held 17–20 September in San Jose, CA. Speakers and attendees come from all over the world to learn, network and exchange ideas. We recently asked a number of RAPS members at various stages of their regulatory careers about the value of attending the Convergence, and here’s what they had to say: “Regulatory Convergence is...
  • RAPSRAPS' Latest

    Bay Area Regulatory Pros Looking Forward to Convergence's Return to San Jose

    The Regulatory Convergence will return to San Jose, CA, in 2016, bringing RAPS’ signature annual event back not only to one of the world’s premier centers of technology and innovation—Silicon Valley—but also to the home of RAPS’ oldest and one of its most active chapters, the San Francisco Bay Area Chapter. RAPS asked some of the local chapter’s volunteers and other local regulatory professionals about what makes the San Francisco Bay Area such a special place, an...
  • Regulatory NewsRegulatory News

    Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators

    The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue. Emer Cooke, head of international affairs at the EMA, said that the Brexit decision, which may cause the agency to leave London, “is a decision that affects a lot of the staff of the agency, p...
  • ReconReconRegulatory NewsRegulatory News

    Regulatory Recon: FDA Approves Allergan Combo Therapy Biden to Launch Database to Advance Cancer Research and More From ASCO 2016 (6 June 2016)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA approves Allergan's combination therapy for hypertension ( Reuters ) ( PR ) Teva Painkiller Resists Snorting, Injection Abuse, FDA Staff Say ( Bloomberg ) Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA ( PR ) ( Reuters ) Supreme Court rejects GSK bid to throw out racketeering lawsuits ( R...
  • RAPSRAPS' Latest

    Disruptive Technologies Expert Ray Wang to Keynote Regulatory Convergence in San Jose, CA

    R “Ray” Wang, principal analyst, founder, and chairman of Silicon Valley-based Constellation Research will deliver the opening keynote Sunday evening, 18 September, at RAPS’ 2016 Regulatory Convergence conference in San Jose, CA. The Convergence, the largest annual gathering of healthcare product regulatory professionals, will be held at the San Jose Convention Center 17–20 September. Wang works with Global 2000 companies on areas including innovation, busines...
  • Regulatory NewsRegulatory News

    New ISO 13485: Device Companies Have Three Years to Transition

    The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003. The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements. Over the next three years, ISO 13485:2003 and ISO 13485:2016 ...