• Regulatory NewsRegulatory News

    Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

    Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies. The ruling is concerned specifically with Supplementary Protection Certificates (SPCs), which extend the duration of certain rights associated with a patent and are typically provided to compe...
  • Feature ArticlesFeature Articles

    The Evolving Approach of Presenting Risk Information to Consumers

    This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency. In recent years, there has been an increased focus from the US Food and Drug Administration (FDA) on consumer directed promotional materials. Nearly all of the active research projects at the Office of Prescription Drug Promotion (OPDP) are focused on how consumers respond to the type or presentation of risk inf...
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    FDA Reverses Long-Standing Policy of Not Publicly Posting Individuals' Comments

    As part of its shift to increase transparency, the US Food and Drug Administration (FDA) said on Thursday that beginning 15 October it will publicly post individuals' comments on the regulations docket. The new policy could potentially have an impact on lobbyists or other special interest groups submitting comments as individuals. "In 1995, FDA explained that it routinely reviewed all comments for obvious confidential information before placing the comments in the docke...
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    Quality Metrics: Industry Reaction to FDA's Draft Guidance

    On Monday, the US Food and Drug Administration (FDA) held a public meeting to discuss its plan to request quality metrics from drug manufacturers. The meeting was the first opportunity for the agency and industry to publicly discuss the plan since FDA released its draft guidance in July . While many questions about the program remain, the agency provided some clarification for industry and said it would not be releasing its final guidance until 2016. The agency is also ...
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    precisionFDA: A Crowd-Sourced, Cloud-Based Platform for Precision Medicine

    The US Food and Drug Administration (FDA) has announced the launch of a new crowd-sourced, cloud-based platform, precisionFDA, to enable developers of genomic sequencing diagnostics to share data and methodologies. precisionFDA In a post to FDA Voice Wednesday, FDA Chief Health Informatics Officer Taha Kass-Hout and Policy Advisor for the Office of In Vitro Diagnostics and Radiological Health David Litwack laid out the plan and goals for precisionFDA. The new platfo...
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    FDA to Study How Efficacy Information Affects Patients' Decisions in Drug Ads

    Does the inclusion of efficacy information in drug advertisements affect how patients perceive a drug, and if so, how would it affect their decision making? These are questions the Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration (FDA) intends to answer through a two-part study just announced in the Federal Register. Background In addition to reviewing drug ads and promotional labeling "to ensure that the information … is not false ...
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    UK to Launch New Office for Market Access

    The UK's National Institute for Health and Care Excellence (NICE) is launching a new office to promote market access for innovative products through early engagement with companies. A proposal and outline for the Office for Market Access (OMA) was approved by NICE's Board of Directors on 20 May 2015. Background When a new medicine is approved in the UK, NICE is responsible for conducting a health technology assessment (HTA) to measure its cost-effectiveness and determ...
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    FDA Kicks off Generic Drug User Fee Reauthorization Process

    Regulators and generic pharmaceutical companies, start your engines. The race to the next reauthorization of the Generic Drug User Fee Act (GDUFA) has begun. In a Federal Register notice on 21 April 2015, the US Food and Drug Administration (FDA) announced that it will begin accepting comments regarding the first-ever reauthorization of GDUFA—a user fee arrangement which funds much of FDA's generic pharmaceutical regulatory activities. Background GDUFA was first pa...
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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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    Do Price Comparisons Affect How Safe Patients Think a Drug is? FDA Plans to Find Out

    The US Food and Drug Administration (FDA) plans to study whether including pricing information on the label of a pharmaceutical product affects how consumers view the safety and efficacy of drug products, especially when comparisons are made between two drugs. Background Pharmaceutical advertising and labeling in the US are regulated by FDA, which ensures that certain information related to the safety and efficacy of a product is conveyed appropriately. The ultimate goa...
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    Leader Sought for FDA's Powerful New Office of Pharmaceutical Quality

    The US Food and Drug Administration (FDA) has big plans to boost the quality of pharmaceutical products through the creation of its new Office of Pharmaceutical Quality (OPQ). But its success perhaps depends on one factor more than any other: Finding the right person to lead the effort. Background The creation of OPQ was  first announced  in September 2012 during a larger reorganization of the Center for Drug Evaluation and Research (CDER) by longtime Director Janet W...
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    Temporary Reshuffle at FDA's Office of Generic Drugs as Leader Takes Medical Leave

    The US Food and Drug Administration's (FDA) top generic drug regulator, Kathleen "Cook" Uhl, is temporarily stepping down to deal with a serious health issue, FDA has confirmed. Uhl has served as head of OGD for two years, first as acting director starting in March 2013, and then as the office's permanent director in January 2015. Under her leadership, OGD has been implementing huge changes spurred by the passage of the Food and Drug Administration Safety and Innovati...