• Regulatory NewsRegulatory News

    FDA official discusses benefits, challenges of remote inspections

    The use of remote regulatory assessments (RRAs) has helped the US Food and Drug Administration (FDA) identify “significantly deficient” good manufacturing practice (GMP) violations when officials cannot visit sites. Yet the program does pose some technical and logistical challenges, which can interfere with a manufacturer’s ability to respond to requests for records.   So asserted Ashar Parikh, foreign pre-approval inspection manager for FDA, who spoke on some of the l...
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    FDA outlines plan for ‘agency-wide approach’ to cybersecurity

    The US Food and Drug Administration (FDA) has released a new action plan for approaching cybersecurity, outlining its mission to upgrade, enhance and modernize its defenses to assets and data at the agency.   “Cybersecurity touches every facet of the FDA’s broad, complex responsibility. It’s one of our agency’s top priorities, and we take it seriously, particularly given today’s increased cybersecurity risks,” Vid Desai, chief information officer and Craig Taylor, chie...
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    FDA official: Most drug GMP warning letters in FY2022 stemmed from onsite inspections

    A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year 2022 were the result of onsite inspections, reversing a pandemic-era trend of enforcement actions triggered by the use of alternative tools.   Yet the agency faces “incredible challenges” going forward, as it tackles a backlog of inspections that were put on hold during the pandemic, asserted Jeffrey Meng, program divis...
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    Stakeholders ask FDA to harmonize adverse events terms with standards orgs

    Pharmaceutical companies are asking the US Food and Drug Administration (FDA) for more adverse events reporting standardization by harmonizing with standards organizations as well as further clarity around key terms. Their comments are in response to a recent workshop on the topic and documents released by the agency.   Lack of standardization of safety data analysis and visualization, as well as inconsistencies in how adverse events are defined, categorized, analyzed,...
  • ReconRecon

    Recon: FDA advisers back Ardelyx kidney disease drug; UnitedHealth to offer Humira alongside biosimilars next year

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US U.S. FDA advisers back Ardelyx's kidney disease drug ( Reuters ) ( Endpoints ) Lab-grown meat cleared for human consumption by U.S. regulator ( Reuters ) ( FDA ) FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease ( FDA ) Roche gets EUA for high-throughput monkeypox test ( MedtechDive ) ( Reuters ) Elizabeth Holmes’...
  • Feature ArticlesFeature Articles

    Excellence and equity: From pilot to program, a Pfizer experience

    In 2021, Pfizer global regulatory affairs colleagues piloted an advanced pharmacy practice experience program as part of a company-wide diversity, inclusion, and equity program in collaboration with Howard University College of Pharmacy (CoP), a US-based historically Black college/university (HBCU). 1 Following pilot success, the initiative was elevated to full program status and the prospective student pool was expanded to include all HBCU CoPs in the US, as well as one ...
  • Feature ArticlesFeature Articles

    Drug preclusion and public health: The case for a narrow interpretation of ‘article’

    The definition of “dietary supplement” in the Food, Drug, and Cosmetic (FD&C) Act includes several provisions limiting what can be a legal dietary supplement based on the ingredients used and delivery form, as well as whether a substance has a history of drug use. This article explores the US Food and Drug Administration’s (FDA’s) use of this last provision, often called “drug preclusion.” The authors examine the history of the provision, Congress’s purported purpose for ...
  • Feature ArticlesFeature Articles

    Foods for special medical purposes/medical foods: A global regulatory synopsis

    This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions – EU, UK, US, China, and other regions of the world – to improve the role of nutrition in support of optimal care for patients. Part 1 covers general principles governing FSMPs, use of FSMPs in community and hospital settings, common regulatory challenges, opportunities for category growth, and considers a multistakeholder initi...
  • RoundupsRoundups

    Euro Roundup: EMA consults on planned update to computerized systems annex of GMP guide

    The European Medicines Agency (EMA) is seeking feedback on the planned revision of the good manufacturing practice (GMP) annex on computerized systems. The agency wants to revise the existing text, which dates to 2011, because it “does not give sufficient guidance within a number of areas.”   Annex 11 applies to all sets of software and hardware components, which EMA defines as computerized systems that are used as part of GMP-regulated activities. The annex is used in...
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    FDA relaxes EUA advertising limitation for some COVID drugs

    The US Food and Drug Administration (FDA) has relaxed a limitation on advertising and promotion for certain COVID-19 drugs with emergency use authorizations (EUAs). The agency said that “truthful and non-misleading” advertising and promotion of COVID-19 therapeutics could benefit the public health, though some caveats to how the drugs can be promoted still apply.   In a memorandum dated 27 October, first reported by AgencyIQ, FDA laid out a new policy giving sponsors...
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    FDA official offers insights on Emerging Technology Program

    The US Food and Drug Administration (FDA) accepts a wide variety of applications into its Emerging Technologies Program (ETP), and is not just focused on continuous manufacturing, said Joel Welch, associate director for science and biosimilar strategy in the agency’s Office of Biotechnology Products.   “I think that sometimes there is a misperception that advanced manufacturing is just about continuous manufacturing,” said Welch who provided an update on the ETP at the...
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    FDA takes first step to allow low-dose OTC naloxone on market

    Low-dose naloxone drug products, including certain nasal sprays and autoinjectors, could one day be sold without a prescription, according to an initial assessment by the US Food and Drug Administration. Though the agency says it needs more data, a final determination could allow naloxone makers to get their product to market with fewer barriers to access than prescription versions of the drug.   Naloxone is used to treat opioid overdoses; proponents of the drug argue ...