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  • Regulatory NewsRegulatory News

    EMA Explains How it Supports Article 58 Applications

    The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs). Background First introduced in Regulation (EC) No. 726/2004 in 2004, the Article 58 procedure allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in collaboration ...
  • Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated

    In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.” The comments, which came before the meeting with CEOs from industry group PhRMA, Merck, Novartis, Johnson & Johnson, Celgene and others, Trump said in terms of the drug approval process: “We’re also going to be streamlining the process, so t...
  • RAPS' LatestRAPS' Latest

    RAPS' New Board of Directors Begins 2017 Term

    The 2017 term for the RAPS board of directors of began officially on 1 January. For the new term, Todd Chermak of Abbott Established Pharmaceuticals takes over as chairman. “I am extremely proud to serve as chairman of the RAPS board of directors,” said Chermak. “RAPS plays an important role in helping regulatory professionals effectively perform their critically important jobs and in promoting regulatory excellence at all levels. I look forward to playing a key r...
  • Regulatory NewsRegulatory News

    BsUFA II: What’s Coming for Biosimilar Sponsors from FY 2018 Through FY 2022

    A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase. FDA Commissioner Robert Califf opened the public hearing with comments on how the agency is still trying to find the righ...
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    FDA Unveils IRB Draft Guidance on Written Procedures

    The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected. Under federal regulations, IRBs are required to maintain and follow written procedures...
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    NIH Finalizes Single IRB Policy to Reduce Redundancies

    The National Institutes of Health (NIH) on Monday finalized a policy that will require NIH-funded clinical studies to be overseen by a single institutional review board (sIRB), beginning in May of next year. NIH made the announcement in a notice published to the Federal Register , saying its goal is to "enhance and streamline the IRB review process" for multi-site clinical trials. Overall, NIH says feedback on the policy was supportive, though some commenters felt the ...
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    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...