• Regulatory NewsRegulatory News

    FDA authorizes new device to help diagnose pediatric autism

    The US Food and Drug Administration on 2 June authorized the marketing of a first-of-its kind device intended to help diagnose autism spectrum disorder (ASD) in children aged 18 months through 5 years.   The device was developed by Cognoa, a company based in Palo Alto, CA, that develops diagnostic devices for the pediatric population. The company submitted its application, for the de novo pathway for new types of low-to-moderate-risk devices in September 2020.   ...
  • Regulatory NewsRegulatory News

    Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation

    A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the US Food and Drug Administration (FDA) to revoke the orphan designation granted to Indivior’s opioid use disorder treatment Sublocade (buprenorphine extended-release injection).   “Sublocade is not now, nor was it ever a bona fide orphan drug, particularly since more than two million Americans currently are afflicted by opioid addiction,” the pe...
  • Regulatory NewsRegulatory News

    FDA Finalizes Buprenorphine Drug Development Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing new types of buprenorphine depot products for medication assisted treatment (MAT) for opioid use disorder amid the ongoing opioid epidemic.   Buprenorphine, along with methodone and naltrexone, are the only drugs approved by FDA to treat opioid use disorder.   Buprenorphine MAT works by reducing patients’ withdrawal symptoms and blocking the euphoric effects of other opioid drug...
  • Regulatory NewsRegulatory News

    FDA to Discuss Autism and Available Treatments in May

    An upcoming public meeting is intended to allow the US Food and Drug Administration (FDA) to obtain patient perspectives on the impact of autism on daily life, as well as views on treatment approaches. Background As part of commitments tied to the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V), under Title I of the Food and Drug Administration Safety and Innovation Act , FDA has selected autism as the focus of a public meeting on 4 May 2017, fr...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA to Revise Trial Guidance on Hemophilia, Crohn’s, Ulcerative Colitis, Diabetes and Bipolar Disorder (4 August 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Boom in Hemophilia R&D Prompts EMA to act to Prevent Enrollment Bottleneck The European Medicines Agency (EMA) is planning to revise its guideline on development of drugs to treat hemophilia to cut the risk of patient enrollment bottlenecks slowing progress. EMA began the process after becoming concerned that the minimum data requirements of its current guideline are i...
  • Regulatory NewsRegulatory News

    EMA Seeks Input on First Guidance for Autism Treatments

    The European Medicines Agency (EMA) on Friday released its first guidance to help drugmakers develop therapies to treat autism spectrum disorder (ASD). The draft guideline seeks to provide advice on four critical areas of clinical development: diagnosis and inclusion criteria for patient selection in clinical trials, methods for assessing efficacy, clinical trial design and measuring drug safety. Currently, ASD treatment focuses primarily on behavioral therapy and speci...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Calls for More Research Into Autism Diagnostic Tools (10 December 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Review Calls on Regulators to Limit Levels of Antimicrobials in Production Plant Wastewater A review commissioned by the British government has called for regulators to limit the levels of antimicrobials in manufacturing plant wastewater. By capping the concentration of antimicrobials in wastewater, regulators may contribute to a stemming of the rise of drug-resistant s...
  • Regulatory NewsRegulatory News

    Following Criticism, FDA to Focus on Female Sexual Disorders at Upcoming Patient Meeting

    The US Food and Drug Administration (FDA) this week quietly announced that it soon plans to hold a meeting on female sexual dysfunction (FSD) as part of a larger effort to bring patients into the drug development process to fine-tune its benefit-risk assessment process. Background The meeting will be the 11th under FDA's Patient-Focused Drug Development process—an initiative created under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to he...
  • FCC Regulation Aims to Promote Medical Device Innovation

    • 30 April 2013
    A new regulation published by the Federal Communications Commission (FCC) would serve to streamline the Experimental Radio Service (ERS), a block of radio spectrum meant to promote innovation, including its medical testing license, now used in some medical device products. Background The ERS is basically a set of rules that "prescribe the manner in which the radio spectrum may be made available to manufacturers, inventors, entrepreneurs and students to experiment with n...
  • Pediatric Challenges Focus of Amended EMA Guideline on Lipid Disorders

    A new pediatric addendum from the European Medicines Agency (EMA) is aimed at highlighting unique challenges facing the development of treatments for pediatric patients with lipid disorders. Primary, or familial, lipid disorders are characterized by an excess amount of lipids or lipoproteins, which can lead to organ-the heart in particular-and tissue damage in the absence of adequate treatment. In children with familial lipid disorders, this damage starts occurring fro...
  • Report Highlights Potential Impact of Spectrum Changes on Medical Device Innovation

    • 23 July 2012
    A new report out by the President's Council of Advisors on Science and Technology (PCAST) makes the case that blocks of carefully managed wireless spectrum may be of increasing importance to future medical device innovation. The report, Realizing the Full Potential of Government-Held Spectrum to Spur Economic Growth , comes just two months after the Federal Communication Commission (FCC) announced its own first-in-the-world plan to dedicate a band of wireless spectrum...
  • FCC Approves First-in-World Plan to Dedicate Spectrum to Networked Medical Devices

    • 24 May 2012
    In an expected move, the Federal Communications Commission (FCC) approved a plan to dedicate a new band of shared spectrum to an emerging class of medical devices known as Medical Body Area Networks (MBANS). MBANS are effectively networks composed of multiple wireless medical devices capable of communicating with one another. FCC had been publicly touting its intent to dedicate the 2360-2400 MHz spectrum band to the emerging MBAN device class since at least April 2012....