• RoundupsRoundups

    Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

    TGA releases guide to classifying active medical devices by risk   New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.   The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU w...
  • Feature ArticlesFeature Articles

    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 ...
  • Regulatory NewsRegulatory News

    CBO: Proposed Medicare pricing plan could curb drug development

    A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.   The Elijah E. Cummings Lower Drug Costs Now Act ( H.R. 3 ), introduced in the 116th Congress during the 2019-2020 legislative session, would require the Secretary of Health and Human Servi...
  • Regulatory NewsRegulatory News

    FDA focuses on efforts made to avert drug shortages in 2020

    New drug shortages in the US decreased in 2020, in part because of the US Food and Drug Administration’s (FDA’s) use of enforcement discretion to ensure an uninterrupted supply of critical medical products during the COVID-19 public health crisis.   Yet, the agency’s new drug shortages report to Congress said that while these actions helped avert shortages in the short-term, more work is needed to improve supply chain resiliency.   This report summarizes the agency...
  • Regulatory NewsRegulatory News

    EMA consults on ICH S12 guideline, shares comments on PFDD reflection paper

    The European Medicines Agency (EMA) on Thursday opened a public consultation on the International Council for Harmonisation’s (ICH) S12 guideline on nonclinical biodistribution (BD) considerations for gene therapies.   The S12 guideline recently reached Step 2b of the ICH process after being endorsed at the ICH Assembly virtual meeting earlier this month. (RELATED: ICH reports ‘significant milestones’ reached on guidelines ranging from impurity testing to eCTD standa...
  • Regulatory NewsRegulatory News

    New laws address NCE exclusivity, biosimilar education

    Two bipartisan bills aimed at clarifying what constitutes a new chemical entity (NCE) and providing education on biosimilars to consumers and physicians were signed into law by President Joe Biden on Friday.   The first bill, S. 415 , also known as the Ensuring Innovation Act , amends the Federal Food, Drug, Cosmetic Act (FD&C Act) to replace the definition of an active ingredient with the active moiety definition used by FDA for the purposes of determining whether...
  • RF Quarterly

    RF Quarterly, March 2021: Global clinical trials

    Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...
  • RF Quarterly

    Planning for a clinical trial application

    In recent years, global clinical trials have become standard, and for a good reason. In broad terms, expanding clinical trials across the world provides a better opportunity for demonstrating the true impact of an investigational drug. Global clinical trials offer key advantages to patients and industry, but smaller companies may be hesitant to participate in global trials, wondering if the inevitable challenges outweigh the benefits. The key considerations in designing a ...
  • RF Quarterly

    The Canadian application process and alternate pathway for COVID-19‒related trials

    This article offers an overview of the clinical trial application process and guidance on the regulatory obligations pursuant to Part C, Division 5, of the Food and Drug Regulations for Clinical Trials Involving Human Subjects in Canada. The authors focus on clinical trial applications only for biologics (schedule D) and pharmaceuticals (schedule F). They provide information on a range of clinical trial submission requirements and communication with Health Canada’s relevan...
  • Regulatory NewsRegulatory News

    FDA pilots program to encourage new drug development tools

    The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.   The qualification process for DDTs was revamped under the 21 st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Anim...
  • Regulatory NewsRegulatory News

    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...
  • RoundupsRoundups

    FDA Approvals Roundup: Fintepla, Dojolvi, Phesgo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Fintepla gets the go-ahead for Dravet syndrome Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.   The approval was based on findings from two clinical studies in 202 participants aged ...