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  • Regulatory NewsRegulatory News

    FDA Faces Sensitive Challenge With Review of DMD Drug

    The blanketing of snow on the East Coast this past weekend prompted the postponement of a high-profile US Food and Drug Administration (FDA) advisory committee hearing for a Duchene Muscular Dystrophy (DMD) drug that is stirring up public controversy and will eventually lead to an up or down decision testing FDA’s resilience to public pressure. The advisory committee meeting, which the Jett Foundation, a DMD advocacy group, said Tuesday will likely be rescheduled withi...
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    Consumer Advocacy Group Warns on Orphan Provisions in 'Cures' Act

    Orphan drug provisions in the House-passed 21st Century Cures Act could increase US healthcare spending by billions of dollars over the next decade, consumer advocacy group Public Citizen warns, though the bill still remains in limbo in the Senate. The provisions in question would add an additional six months of marketing exclusivity for approved drugs that later go on to be approved to treat rare diseases. The extended period of exclusivity would apply to all indicati...
  • Feature ArticlesFeature Articles

    US Preparedness for Public Health Emergencies: Medical Countermeasures and Emergency Use Authorization

    This article discusses how medical products needed during public health emergencies can be made available to the public through the use of FDA's Emergency Use Authorization (EUA). During public health emergencies, the US government must respond quickly. Medical countermeasures (MCMs) are medical products, such as drugs, vaccines and diagnostic tests needed during an emergency. MCMs are developed, manufactured, procured, stockpiled and distributed to protect or treat th...
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    FDA to Host Public Meeting on Psoriasis Patient Perspectives

    The 17 March 2016 public meeting at the US Food and Drug Administration (FDA) will allow for patients to offer their unique perspectives on the impact of psoriasis, including on daily life and treatment options. FDA says it’s interested in “patients’ perspectives for the types of psoriasis with primarily skin symptoms (such plaque psoriasis, nail psoriasis, guttate psoriasis, etc.), patient views on treatment approaches, and decision factors taken into account when selec...
  • Feature ArticlesFeature Articles

    Do Public Hearing Participants Influence Outcomes of FDA Advisory Committee Meetings?

    This article discusses the importance of the open public hearing portion of an FDA Advisory Committee meeting. Many regulatory changes have impacted the US Food and Drug Administration (FDA) approval process for new drugs and medical devices, including the requirement from the Food and Drug Administration Amendments Act for an Advisory Committee review. Advisory Committees provide the agency with advice from outside experts on issues related to drugs, biological prod...
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    Tougher FDA Approval Process for Opioids Sought by Congress

    New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). Background The bill, the FDA Accountability for Public Safety Act (FAPSA) , is a response to FDA's regulation of opioid painkillers, and specifically one known as Zohydro. The drug was approved in October 2013 as a pure hydrocodone product lacking any physical characteristi...
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    EU Considers Major Revisions to Veterinary Medicines Regulations

    The European Parliament is considering major changes to how veterinary medical products are regulated in the EU. At the upcoming meeting of the Environment, Public Health and Food Safety (ENVI) committee on 18 March 2015, members will discuss a proposal for a new regulation which is intended to overhaul the regulation of veterinary medicines and streamline the European market for veterinary medicinal products. Background Veterinary and human medicines regulations in th...
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    Canada Launches Ebola Vaccine Trial

    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. The Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV), Canada's Minister of Health, Rona Ambrose, announced last week.  The Canadian Im...
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    With $5 Million Grant, FDA Wants to Change how the US Responds to Future Public Health Emergencies

    A new $4.9 million contract awarded by the US Food and Drug Administration (FDA) seeks to improve how the agency deploys medical countermeasures during public health crises like Ebola. Background "In emergency situations, rapid response is critical," FDA writes on its website. And while that response often includes basic provisions—money to buy supplies and the deployment of healthcare providers to an area, for example—it almost always includes medical products like dru...
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    Public View of FDA Continues to Improve in New Poll

    More than half of the US public believes that the US Food and Drug Administration (FDA) is doing a good or excellent job, according to a recent survey sponsored by the pro-regulation group Coalition for Sensible Safeguards. The survey, based on a nationwide survey in July 2014 of 700 likely voters from around the country, quizzed respondents on their views of the US government and its many regulatory agencies. Respondents were relatively split on their view of the fe...
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    Public Comment Period Opens on ISO 9001, Major Device Quality Standard

    The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation. Background The standard, which covers Quality Management Systems (QMS), undergoes  a revision process once every five years, and was last updated in 2008 (ISO 9001:2008). The ISO 9001 standard is used extensively throughout the medical...
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    Public Citizen Again Calls for Ban on Diabetes Drug Victoza

    A prominent consumer watchdog group is calling on the US Food and Drug Administration (FDA) to withdraw its approval of the diabetes drug Victoza (liraglutide), which it says is linked to acute pancreatitis and several deaths. Background Victoza was approved by FDA in 2010 as a once-daily injectable treatment for Type 2 diabetes. The drug is an incretin mimetic drug known as a glucon-like peptide-1 (GLP-1) receptor agonist. At the time of its approval, FDA noted...