• Regulatory NewsRegulatory News

    Dose banding: FDA aims to reduce drug waste in new labeling guidance

    The US Food and Drug Administration (FDA) has released draft guidance to assist sponsors with incorporating dose banding information in drug labeling for ready-to-use containers in new drug applications (NDAs), biologics license applications (BLA) or supplements to those applications.   Dose banding refers to dosing a drug product based on weight or body surface area (BSA), and labeling can include a range of different strengths.   This approach reduces “signific...
  • Regulatory NewsRegulatory News

    FDA offers new guidance on therapeutic equivalence evaluations

    In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment of therapeutic equivalence codes, which are listed in the agency’s Orange Book and provide information about whether drugs are bioequivalent and can be substituted for one another.   “Therapeutic equivalence evaluation have been prepared to serve as public information and advice to state health agencies,...
  • ReconRecon

    Recon: CDC clears fourth COVID-19 vaccine; Merck’s Keytruda hit with setback after failed head and neck cancer trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A fourth Covid vaccine is cleared for use in the United States. ( NYT ) ( STAT ) ( Reuters ) ACIP Nod For Novavax’s COVID Vaccine Comes With Criticism On Lack Of Expiration Date Packaging ( The Pink Sheet ) FDA carryover funds to pay staff to last until November, Burr says ( Politico ) FDA slaps ImprimisRx with a warning letter over sponsored articles in medic...
  • Regulatory NewsRegulatory News

    Pharmaceutical industry groups suggest modifications to ICH Q9 guideline

    Pharmaceutical industry groups in the US suggested the International Council of Harmonization’s (ICH) Q9(R1) guideline on risk management be revised to better reflect the principles of the ICH Q10 guideline on effective quality management systems. Industry groups in the US and the Europe also recommended that forthcoming training materials provide more concrete examples showing how specific risk management principles can be applied.   These comments were in response ...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA posts 2022-2023 priorities for import, advertising, supply compliance

    Australia’s Therapeutic Goods Administration (TGA) has published its compliance priorities for imports, advertising and supply. The list of priorities, which is topped by actions against unapproved COVID-19 products, covers the agency’s 2022 to 2023 financial year.   The list includes seven compliance priorities. First up: to “deter and address the unlawful import, advertising and supply of unapproved therapeutic goods associated with COVID-19.” To do so, TGA will prov...
  • 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...