• ReconRecon

    Recon: Inovio to lay off 18% of its staff; EU signs COVID-19 procurement deal with Gilead

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The politics of passing a major FDA funding bill just got complicated ( STAT ) FDA approves first at-home therapy for skin repigmentation in vitiligo patients ( STAT ) Biotech employees cash in health care’s largest salaries, while people working at providers sit near the bottom ( STAT ) Dozens of lawmakers urge HHS to fine drugmakers for curtailing discounts ...
  • RF Quarterly

    RF Quarterly, June 22: Regulatory history

    Welcome to the June issue of RF Quarterly in which global regulatory experts write about Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), medical device regulations in China’s National Medical Products Administration (NMPA), and a personal reflection on 3 decades at the International Council for Harmonisation (ICH). Also included are articles on the development of clinical trial disclosure requirements, expedited pathways, and the De Novo pathway and the Final Ru...
  • RF Quarterly

    The evolution of the De Novo pathway

    This article provides an overview of the regulatory history of the De Novo pathway, from its initial introduction in the Food and Drug Administration Modernization Act (FDAMA) in 1997 to its Final Rule implementation into the US Federal Regulation via 21 CFR 860 in 2022. The authors provide a summary of each of the establishing acts and guidances that have culminated in the regulation, emphasize the historic changes of the process, and provide an analysis of the impact of ...
  • RF Quarterly

    A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP

    It can take at least a year to 18 months to get a new medicinal product approved in the US, European Union, or United Kingdom. Over the last decade, regulators have introduced initiatives to shorten the time to market for medicines that address seriously debilitating and life-threatening conditions. This article reviews the initiation and achievements of US Food and Drug Administration’s (FDA’s) breakthrough therapy designation (BTD), the European Medicines Agency’s (EMA) ...
  • Feature ArticlesFeature Articles

    Managing regulation of mental health-related claims in the COVID-19 era

    As we enter the third year of the COVID-19 pandemic, consumers are increasingly turning to dietary supplements to help them manage the daily stress of this unprecedented time. However, as demand for dietary supplements associated with stress and anxiety-reduction has increased, so has regulatory scrutiny from the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC). This article provides an overview of the FDA and FTC’s regulations and enforcement activ...
  • Feature ArticlesFeature Articles

    Proposed updates hint at dietary supplement legislative reform

    The dietary supplement industry has grown in the 28 years since the passage of the Dietary Supplement Health and Education Act (DSHEA), but the legislative reform has not been commensurate with those industry changes. This article discusses six key legislative updates proposed by FDA, industry, and consumer groups, suggesting reform is on the horizon for DSHEA.   Keywords – dietary supplement, Dietary Supplement Health and Education Act, DSHEA, CBD, hemp, listing, ...
  • Feature ArticlesFeature Articles

    Supply chain disruptions: FDA guidance and temporary policies

    The COVID-19 pandemic caused one of the most prominent displays of supply chain disruption in the modern era. However, the US Food and Drug Administration (FDA) found ways to allow for regulatory flexibility by issuing guidance documents while still managing to protect consumers from adulterated and misbranded food.   Keywords – COVID-19 , FDA, food, guidance, pandemic, supply chain   Introduction The complexity of modern supply chains is never more eviden...
  • Regulatory NewsRegulatory News

    Industry asks FDA to expand scope of product quality assessment guidance

    Corrected 21 July 2022 to make a clarification about the products subject to the industry comments.   Stakeholders want the US Food and Drug Administration (FDA) to include biosimilars, as well as certain biologics regulated by the Center for Biologics Evaluation and Research (CBER), in the agency’s guidance on benefit-risk principles when evaluating product quality assessments.   In May, FDA published the Benefit-Risk Considerations for Product Quality Assessm...
  • Regulatory NewsRegulatory News

    European Commission proposes overhaul of blood, tissues and cells regulation

    The European Commission (EC) last week proposed to overhaul the EU’s regulations on substances of human origin (SoHO) to improve the quality and safety of substances that are part of treatments and therapies like blood transfusions, stem cell transplants for blood cancers and medically assisted reproduction therapies such as in vitro fertilization (IVF).   The regulation, which is part of the European Health Union initiative, would not only cover better quality and saf...
  • ReconRecon

    Recon: CDC says monkeypox vaccine demand exceeds supply; NIH’s Fauci to retire by end of Biden’s term

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Demand for Monkeypox Vaccine Exceeds Supply, C.D.C. Says ( NYT ) ( Politico ) US Buys More Monkeypox Vaccine, Ramps Up Testing as Cases Rise ( Bloomberg ) ( Endpoints ) NYC will use a one-dose monkeypox vaccine strategy to stretch supplies, despite FDA, CDC warnings against the move ( STAT ) ( Politico ) Covid-19 public health emergency extended in the US ( CN...
  • Regulatory NewsRegulatory News

    This Week at FDA: User fee reauthorization hits a snag, Novavax EUA, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, top Republican on the Senate health committee introduced a “clean” FDA user fee reauthorization bill that could throw a wrench into the already tight timeframe for the package. We also saw FDA authorize Novavax’s adjuvanted COVID-19 vaccine and learned that the agency has dela...
  • Regulatory NewsRegulatory News

    FDA finalizes instructions for use guidance for drugs, biologics

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the content and format of Instructions for Use (IFU) labeling for pharmaceutical manufacturers to help consumers understand complicated instructions for using a drug or a biologic.   The guidance covers human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA)....