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  • Feature ArticlesFeature Articles

    Using risk management to support outsourcing activities

    This article outlines organizational risks and benefits with respect to third-party vendors and partnerships in regulatory affairs functions. It also discusses the different controls available to apply an effective risk management program in an organization.   Introduction   The use of contracted or third-party services can be an effective way for organizations to resource projects or programs. This way of working has been a growing trend in business operations, e...
  • Regulatory NewsRegulatory News

    FDA Modifies REMS Program for Clozapine

    The US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.   Background   Clozapine, which is marketed as Clozaril, Fazaclo ODT and Versacloz, is an antipsychotic drug first developed in the late 1950s and was first approved by FDA in 1989. Clozapine is indicated for the treatment of schizophrenia in patients whose symptoms are not ad...
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    Are You a Rising Regulatory Leader? Learn Business Skills at RAPS Executive Development Program

    As William C. Putnam, PhD, RAC, argues in a  Regulatory Focus  thought piece  on the need for business skills within the regulatory profession, "regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training."  Regulatory Strategy Critical for Business Success The reasons for this are pretty clear. Regulatory issues can ...
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    Why Regulatory Professionals Need Business Training

    You are the senior regulatory professional in the board room overseeing a major development program. The program looks promising and all you need to be concerned about is the most expeditious and risk-free regulatory path to approval, right? Unfortunately, that is not the case. The regulatory development path is typically much more complex and there are many business factors that drive the ultimate development strategy design. The most successful development programs tak...
  • Regulatory NewsRegulatory News

    Gottlieb: Immediate Release Opioids to be Subject to REMS

    FDA Commissioner Scott Gottlieb on Thursday said that immediate-release (IR) opioids will be subject to the same risk evaluation and mitigation strategy (REMS) as extended-release and long-acting (ER/LA) opioids. The agency first required a REMS for ER/LA opioids in 2012. "This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements,...
  • Regulatory NewsRegulatory News

    House Committee Probes Restricted Distribution Systems Delaying Generics

    • 24 March 2017
    • By
    The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition. In his opening statement, Subcommittee on Health Care, Benefits and Administrative Rules Chairman Rep. Jim Jordan (R-OH) said that some drugmakers are manipulating the regulatory framework to block competitors from accessing the reference drugs they need to conduct bioequivalence testing t...
  • Feature ArticlesFeature Articles

    Small Organizations, Big Regulatory Strategy

    This article discusses how small and young organizations, including start-ups, build powerful regulatory strategy programs that complement their research and business development efforts. Established businesses also can learn from their innovative approaches. These include navigating incentives, understanding and utilizing technology tools for regulatory intelligence like social media and crowdsourcing, and embracing a team mentality to build agile and efficient regulato...
  • Regulatory NewsRegulatory News

    Evolving Partnership: EMA Looks to Expand Work With Academia

    The European Medicines Agency (EMA) is intent on establishing a firmer framework for its work with academia as the agency needs to keep abreast of advances in science and continue to hone its regulations. Currently, like in the US, academia provides the European drug regulatory system with thousands of experts to ensure new treatments are evaluated and monitored to the highest scientific standards. And as advances lead to new medicines developed, manufactured, assessed...
  • Regulatory NewsRegulatory News

    EU's New Centralized Pharmacovigilance Portal Gets Endorsement from EMA

    A year from now, drugmakers in the EU will be required to submit postmarket safety reports to an online central repository, the European Medicines Agency (EMA) has confirmed. Background In January 2015, EMA announced the launch of a central repository , hosted on the eSubmissions website, for submitting periodic safety update reports (PSURs). In the EU, drugmakers are required to submit PSURs to EMA at regular intervals. These reports are evaluated and used to en...
  • Feature ArticlesFeature Articles

    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
  • Regulatory NewsRegulatory News

    What's the Best Time to Submit a 510(k) Application to FDA?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com .  What if there was a particular month when your submission would be cleared f...
  • Regulatory NewsRegulatory News

    Australian Regulators Lift Ban on HIV Self-Test Kits

    Following a public consultation, Australia’s Therapeutic Goods Administration (TGA) has announced that the Secretary of the Department of Health has lifted the ban on the sale of HIV self-tests. The decision is aligned with the Seventh National HIV Strategy (2014-2017) , which aims to increase detection of HIV in the community by enabling greater access to HIV self-test kits that have been assessed for quality, safety and performance by the TGA. As a result of t...