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  • Feature ArticlesFeature Articles

    Emergency use authorizations for IVDs: Building on lessons learned

    Emergency use authorization (EUA) is a tool used by the US Food and Drug Administration (FDA) for providing quick access to unapproved medical products in response to a public health emergency. In vitro diagnostics (IVDs) have been critical EUA products in past emergencies and have proven equally important during the COVID-19 pandemic. For regulatory professionals, the valuable lessons learned from EUA policy and ensuing changes over time have provided a crucial foundation...
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    Regulatory pathways for innovative medicinal products for Switzerland

    Switzerland is not part of the EU or the European Economic Area (EEA), therefore, a national marketing authorization application (MAA) for Switzerland must be filed and approved before a medicinal product can be placed on the Swiss market. Besides the standard MAA procedure, there are expedited, simplified, and work-sharing procedures that can be selected, depending on the product characteristics. This article provides an overview of relevant Swiss marketing authorization ...
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    The changing regulatory landscape for laboratory developed tests

    The COVID-19 pandemic has highlighted the importance of reliable and accurate diagnostic tests. Laboratory developed tests (LDTs) do not typically require premarket review. The US Food and Drug Administration (FDA) has repeatedly proposed more rigorous regulatory frameworks for LDTs but has been unsuccessful owing to concerns about the impact on test availability and innovation. In this article, the authors describe the existing regulations and consider both sides of the d...
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    Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers

    This article examines regulatory considerations for emergency use authorizations for medical device manufacturers in response to the COVID-19 pandemic. The authors summarize the four phases of issuance as:  phase 1 ‒ in vitro diagnostic products; phase 2 ‒ personal protective equipment; phase 3 ‒ ventilators and components; and phase 4 ‒ other relevant medical devices. They emphasize the EUA is subject to statutory limits tied to the end of the public health emergency and ...
  • Regulatory NewsRegulatory News

    House, Senate Pass Compromise Bill on FDA, DoD Emergency Use Authorizations

    The US Senate and House of Representatives this week passed a bill forging a compromise over a controversial provision in the National Defense Authorization Act for Fiscal Year 2018 ( NDAA ) that would have allowed the Department of Defense (DoD) to authorize the use of medical products on an emergency basis. The bill is partly the result of criticism raised over the US Food and Drug Administration’s (FDA) sluggishness in approving a French freeze-dried plasma pr...
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    EMA Backs Six Drugs, One Biosimilar for EU Approval

    The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval. The six medicines the agency is recommending are: Dr. Falk Pharma's Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the esophagus. Jorveza was granted an accelerated assessment and orphan designation; Merck Sharp & Dohme's Pr...
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    House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA

    The House of Representatives' Rules Committee on Monday will take up a provision that would expand the US Department of Defense's (DoD) ability to approve, on an emergency basis, medical products, as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb pushed for the provision to be rejected. According to the committee's conference report on the National Defense Authorization Act for FY 2018, the House will add the Senate amendment to authorize the s...
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    FDA Sends Three Letters Over Unapproved Zika Diagnostics

    The US Food and Drug Administration (FDA) is taking steps to enforce its oversight of diagnostic tests used to detect the Zika virus, with three new letters to two laboratories and two Texas hospitals for marketing what it says are "high risk" unapproved diagnostics. The letters, sent to MD Biosciences, First Diagnostic Corp. and two Texas hospitals, Texas Children's and Houston Methodist Hospital, call on the recipients to contact the agency within seven days to discuss...
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    FDA and EMA Share Perspectives on Evaluating Ebola Treatments

    Officials from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have shared their perspectives on evaluating treatments for Ebola in two articles appearing in Clinical Trials . The articles discuss some of the challenges the Ebola outbreak presented for studying drugs and vaccines to treat the disease. At the time the outbreak began, no products existed to treat Ebola, and those that were in development had not been tested in humans. Study ...
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    Registration Procedures for Medicinal Products in China

    This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs. An increasing number of pharmaceutical companies based outside China are interested in marketing their products in China as evidenced by the increasing number of clinical trial and marketing applications submitted by foreign companies. Obtaining marketing authorization approval equal to an Import Drug License (IDL) approv...
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    EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record

    In 2015, the European Medicines Agency (EMA) maintained its momentum from 2014 , granting 93 positive opinions, 39 of which were for new active substances. The agency also recommended 18 orphan drugs for approval, breaking last year's record of 17. Notably, EMA trailed just behind the US Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) for the year. In 2015, CDER approved 45 new drugs, 21 of which had been granted orphan drug designati...
  • Regulatory NewsRegulatory News

    European Commission to Evaluate EMA’s Fee System

    Late next year, the European Commission will begin reviewing the pharmaceutical company fee system that helps fund the European Medicines Agency (EMA). “The effectiveness and the efficiency of the system will be examined notably with respect to the sustainability and the fairness of the financial model of the fees charged by EMA to industry at large, including the remuneration paid by EMA to rapporteurs and experts from national competent authorities,” the commission sai...