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  • Regulatory NewsRegulatory News

    GPhA: Congress Needs to Work With FDA to Increase Generic Competition

    The Generic Pharmaceutical Association (GPhA) has offered three key recommendations to Congress on how to work with the US Food and Drug Administration (FDA) to increase generic competition, according to a new report issued Tuesday. ANDA Backlog First, like Hillary Clinton and many others in the past, GPhA is calling on Congress to take action to reduce the backlog of abbreviated new drug applications (ANDAs) awaiting FDA approval. The association says Congress should...
  • RAPS' LatestRAPS' Latest

    RAPS Award Winners Reflect on Importance of Regulatory Profession and Giving Back

    Each year, when the recipients of RAPS' prestigious annual awards for outstanding contributions to the regulatory profession take the stage at RAPS' annual Regulatory Convergence conference, they find themselves somewhere unfamiliar to most regulatory professionals-in the spotlight. Annually, RAPS bestows upon a select group of worthy honorees, several awards for exemplary professional leadership, volunteerism, mentoring and advancement of the regulatory profession, whi...
  • Flurry of Year-End Drug Approvals Makes 2012 Best Year for Approvals Since 1997

    The US Food and Drug Administration (FDA) has ended the year on a high note, approving a flurry of new pharmaceutical products, taking its 2012 approval total to a 15-year high. US regulators approved at least seven high-profile and mostly new drug products during the final two weeks of 2012, including: Varzig (varicella zoster immune globulin preparation) - Cangene Corporation : Approved for reducing the severity of chicken pox infections in high-risk individuals. ...
  • FDA's Two-year Approval Record Marks 15-Year Best, Report Finds

    The US Food and Drug Administration (FDA) has approved the same number of drugs during the 2012 fiscal year as it did in 2011, a new FDA report claims-the best two-year approval record in 15 years. The agency's "Fiscal Year 2012 Innovative Drug Approvals" report notes that FDA has already "used expedited approval authorities and flexibility in advising sponsors on clinical trial design to approve 35 new novel drugs" this past fiscal year (1 October 2011 through 30 Sept...
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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...
  • Budget Passes Senate, Leaving User Fees at 2012 Levels

    Both chambers of Congress have now passed a continuing resolution that would keep the government's-and the US Food and Drug Administration's (FDA)-budget at existing fiscal year 2012 levels, averting a government shutdown but also leaving in limbo several important FDA programs. Legislators scrambled on 21 September to pass a legislative fix for the establishment of fees for generic drug products, but did not establish similar exemptions for prescription drug, medica...
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    RAPS Announces Spring 2012 Class of RACs

    • 31 August 2012
    The Regulatory Affairs Professionals Society has announced the names of the 203 individuals who earned their Regulatory Affairs Certification during the spring 2012 RAC exam period. Along with the Regulatory Affairs Certification Board, RAPS extends sincere congratulations to these accomplished professionals. Following is the full list of the spring 2012 RAC class. RAC Canada Bradley Abbott Purvi Agrawal Nicholas Allard Maha...
  • Feature ArticlesFeature Articles

    What RAPS' Scope of Practice Survey Tells Us About the Regulatory Talent Pipeline

    The Regulatory Affairs Professionals Society (RAPS) released the results of its biennial Scope of Practice & Compensation Survey of the Regulatory Profession in July 2012. For this research, RAPS asked those involved in the regulation of healthcare and related products to answer questions about their daily work, employment, compensation rates and background. Nearly 3,000 regulatory professionals from around the world responded. Their answers about their work experi...