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  • RAPS' LatestRAPS' Latest

    Updated: RAPS Calls for Board Nominations Deadline Extended to 1 June

    RAPS has opened the nomination process for four open positions on its board of directors for the 2017–19 term. Regulatory leaders are needed to serve as president-elect, treasurer and directors (two open positions). Nominations and supporting materials, including resume or curriculum vitae (CV) and two letters of support, must be submitted to RAPS by 1 June 2016. Nominees must be active RAPS members in good standing. “This is a great opportunity to lead the pre...
  • Regulatory NewsRegulatory News

    FDA Warns Monmouth Medical Center IRB Over Conflict of Interest Issues

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Monmouth Medical Center, a New Jersey hospital, after an inspection of its institutional review board (IRB) found it failed to follow regulations meant to protect clinical trial participants, including for pediatric studies. Specifically, the IRB failed to adequately document whether clinical investigations involving pediatric subjects were in compliance with FDA regulations, or document wh...
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    European Regulatory Roundup: EMA Revises Conflict of Interest Rules for Board Members (21 January 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Adopts Strategy to Monitor Effects of Risk-Minimization Measures The Pharmacovigilance Risk Assessment Committee (PRAC) has implemented a strategy to enable it to measure the impact of its activities. Officials have designed the strategy to deliver feedback on the effectiveness of risk-minimization measures and other actions. PRAC, a part of the European Medicines Agen...
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    EMA Management Board Adopts New Framework for Industry Interactions

    The European Medicines Agency’s (EMA) Management Board has adopted a framework that seeks to streamline and structure industry-agency communications, as well as to increase transparency around those discussions. The framework , first announced in early October, comes as the agency has grown in size and scope to the point where its approach to managing interactions with industry have become fragmented. The interactions will cover areas of common interest for the agency a...
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    FDA Science Board Calls on Agency to Find New Ways to Stimulate Biomedical Innovation

    The US Food and Drug Administration (FDA) has made “significant strides” in strengthening its scientific capabilities, though there is still some concern about the agency’s ability to support and stimulate biomedical innovation, according to a new report from a subcommittee of FDA’s Science Board. Background Six years after a 2007 report from the Science Board -- which, among other findings, called attention to FDA’s “weak scientific base and inadequate scientific wor...
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    Eight Years on, FDA Celebrates its Scientific Advancement

    Last week, the US Food and Drug Administration announced the release of a new report, FDA Science Moving Forward, showcasing the agency's scientific advancements since 2007. Major Changes Since 2007                                                                                  In 2007, FDA's Science Board released a report, FDA Science and Mission at Risk, which predicted that "rapid developments" in emerging scientific disciplines such as genomics, personalized ...
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    RAPS Announces New Board Slate

    The RAPS Nominating Committee has announced its slate of one new officer and three directors nominated to serve on the RAPS board of directors for terms beginning January 2016. Current board member Susumu Nozawa, RAC, FRAPS, director, technical and regulatory policy/corporate regulatory affairs for BD, has been nominated to serve as the body’s next president-elect. The president-elect serves in that role for one year before succeeding to become president, then chai...
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    RAPS Seeks Board Nominations

    RAPS is seeking regulatory leaders to serve on its board of directors for the 2016–2018 term. Nominations and all supporting materials, including resume or curriculum vitae (CV) and two letters of support, are due to RAPS by 1 May 2015. Nominees must be full members in good standing. RAPS is looking to fill the positions of president elect and three directors. The board is the organization’s strategic governing and policy body. To submit a nomination, first revie...
  • Regulatory NewsRegulatory News

    India Proposes to Waive Phase III Trials for Drugs Approved in a 'Well-Regulated Country'

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Drugs Technical Advisory Board (DTAB) has recommended granting Phase III clinical trial waiver to some drugs approved in "well-regulated" countries like the US or EU. The waiver would also require drug sponsors to agree to implement a four-year post-marketing s...
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    Potential Medical Device Regulatory Changes Coming to India in 2015

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. India’s health ministry, the Department of Health and Family Welfare, will submit proposed changes to the country’s medical device and pharmaceutical laws to Parliament in 2015. The proposed  Drugs and Cosmetics (Amendment) Bill , 2015  would adopt definitions of medical devices as well as in vitro diagnostic (IVD) products more in...
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    EMA Scrambles to Consider Options After Leader Ousted

    Members of the European Medicines Agency (EMA) met last week to consider an unprecedented question: How should they select a new, permanent leader after they were forced to fire the last one? Background On 13 November 2014, the EU Civil Service Tribunal found that Guido Rasi, then EMA's executive director of three years, had been appointed through an improper selection process and that his appointment would be annulled. At the time, a seemingly stunned EMA said ...
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    EMA Re-Elects Former MHRA Regulator to Lead Influential Management Board

    The European Medicines Agency (EMA) has announced the re-election of Sir Kent Woods as the chair of its influential 35-member Management Board, which sets regulatory policies for the agency. Woods, who served as chief executive at the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) between 2004 and 2013 , will now serve as the board's chair for a final three-year term, after which time term limits preclude him from running again. Woods said in ...