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    RAPS Fellows Share Experiences, Insight and Advice for the Next Generation

    When the Regulatory Affairs Professionals Society (RAPS) honored its 2012 class of RAPS Fellows last October during 2012 RAPS: The Regulatory Convergence in Seattle, the  12 newest Fellows joined an exclusive group of highly accomplished leaders. The  RAPS Fellows program recognizes senior regulatory professionals for their continued contributions, vision and dedication toward the advancement of the profession. Given that regulatory, as a profession, is rela...
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    FDA, Industry Outline Impact of PDUFA V at 2012 RAPS

    Renewed every five years, the Prescription Drug User Fee Act (PDUFA)  is one of the single most important and successful pieces of legislation affecting both the US Food and Drug Administration (FDA) and the pharmaceutical and biopharmaceutical industries. The legislation, originally conceived and passed in 1992, operates on a relatively simple principle: in return for industry-paid user fees, FDA is responsible for hiring additional staff with which to review drug...
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    Regulatory Experts Urge Caution With Communications Activities

    The Office of Prescription Drug Promotion (OPDP) and its Advertising and Promotional Labeling Branch (APLB) of the US Food and Drug Administration (FDA) have been busy. Over the past year, they have released multiple guidances, expanded the so-called "bad ad" program that asks healthcare professionals to police inappropriate promotional efforts, and issued a number of untitled and Warning Letters. During a panel discussion at 2012 RAPS: The Regulatory Convergence , regu...
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    Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media

    When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle. The speakers, Center for Medicine in the Public Interest Founder Peter Pitts; Head of Emerging Technologies, Devices Division for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) Ne...
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    Regulatory Professionals, Top Regulators From Around the World to Converge in Seattle for 2012 RAPS

    In a few weeks, 2012 RAPS: The Regulatory Convergence will bring approximately 70 healthcare regulators and some 2,000 total attendees from around the world to Seattle. The regulatory officials scheduled to speak represent national and international agencies overseeing health products, including 36 speakers from the US Food and Drug Administration (FDA), as well as representatives from agencies in Europe, China, Japan, India, Brazil, Canada and more. The Regulatory Conv...
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    As 510(k) Process Evolves, Questions Remain

    The 510(k) premarket notification process provides a clearance pathway for new, low-risk medical devices to be sold in the US by proving to the US Food and Drug Administration (FDA) that a proposed product is substantially equivalent to another, existing, legally marketed device. But the process has come under fire from critics in Congress and others who have called it a "loophole" that allows devices onto the market without putting them through a rigorous approval proces...