• Feature ArticlesFeature Articles

    Accelerating drug development and approvals in India

    India’s Central Drugs Standard Control Organization (CDSCO) implemented the New Drugs and Clinical Trials Rules in 2019 to expedite the drug development and approval processes. This article provides an overview of those processes; explains the rule-specific terminology, such as the definitions of “drug” and “new drug” under Indian law; and outlines strategies for speeding up the approval processes and optimizing registration of prescription medicines in India.   Keywo...
  • Regulatory NewsRegulatory News

    FDA draft guidance aims to ensure accurate measurements of pediatric growth

    Joint draft guidance from two centers at the US Food and Drug Administration (FDA) outlines ways sponsors can measure pediatric growth consistently in clinical trials for drugs used to treat both rare and common diseases.   “If an investigational drug or biological product may affect growth or pubertal development, then accurate, serial measurement and recording of growth parameters are essential for data interpretation in pediatric clinical trials,” the agency announc...
  • Regulatory NewsRegulatory News

    FDA releases draft guidance to spur development of CDI drugs

    The US Food and Drug Administration (FDA) has issued new draft guidance with advice for sponsors on developing drugs for treating Clostridioides difficile infection (CDI).   The draft provides recommendations for designing these trials and covers trial populations, efficacy and safety endpoints, nonclinical studies, and pharmacokinetic studies. The guidance does not address fecal microbiota transplant products.   CDI is an anaerobic, gram-positive, spore-forming ...
  • Regulatory NewsRegulatory News

    Convergence: EU official says no delay to CTIS implementation, despite industry concerns

    PHOENIX, AZ – Country-specific requirements that diverge from the Clinical Trials Regulation (CTR) and the lack of a forum for resolving issues with the Clinical Trial Information System (CTIS) portal were among the key issues industry representatives brought to a session at RAPS Convergence 2022.   Another problem is that the portal does not flag or send information to sponsors when new information is received, so sponsors must check frequently for updates.   In t...
  • Regulatory NewsRegulatory News

    EU adopts 10-part workplan to guide the acceleration of clinical trials

    The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted ten priorities as part of a larger workplan to  accelerate the adoption of clinical trials in the EU. The priorities are meant to steer the agencies’ work from 2022-2026.   The workplan was adopted under the auspices of the EC-HMA-EMA initiative Accelerating Clinical Trials in the EU (ACT EU), which launched earlier this year. (RELATED: EU launch...
  • Regulatory NewsRegulatory News

    EMA reports steady rise in clinical trial applications registered in CTIS portal

    Nearly 195 clinical trial applications (CTAs) have been submitted to the European Medicine Agency’s (EMA) Clinical Trial Information System (CTIS) portal through July, marking a substantial increase from a month earlier, according to a 23 August report from the agency.   However, during the same period, most applications (224) were still being registered in the older EudraCT database. (RELATED: EMA reports slow uptick in clinical trial applications submitted via CT...
  • Regulatory NewsRegulatory News

    EMA reports slow uptick in clinical trial applications submitted via CTIS portal

    The number of applications filed through the Clinical Trial Information System (CTIS) portal continues to grow, even while most applications are still being filed in the current EudraCT system, according to a 28 July report from the European Medicines Agency (EMA).  Stakeholders offered a mixed assessment of their user experience at recent forum.   Starting in January 2023, CTIS will replace the EudraCT portal and clinical trial sponsors must use the CTIS portal to a...
  • Regulatory NewsRegulatory News

    Neonatal drug development addressed in FDA final guidance

    The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is meant to address gaps in neonatal labeling and encourage the development of therapies that are “unique to neonates.”   The guidance is tailored to sponsors developing these studies for investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications ...
  • Regulatory NewsRegulatory News

    FDA describes plans to expand remote regulatory assessments

    The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as it eases out of pandemic response mode. The guidance covers triggers for when FDA will request or require remote assessments and how these audits will be coordinated with onsite inspections.   These tools are not intended to replace onsite inspections but inste...
  • 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...
  • Regulatory NewsRegulatory News

    EMA to explore reviewing raw data from clinical trials in applications

    The European Medicines Agency (EMA) is looking for industry participants for a pilot assessing whether reviewing raw clinical trial data improves its evaluation of marketing authorization applications (MAAs) for new medicines and post-authorization applications.   The pilot , announced on 12 July, stems from a joint workplan announced by EMA and the EU’s Heads of Medicines Agencies (HMA) to address issues related to big data in healthcare and medicines development. On...
  • Regulatory NewsRegulatory News

    FDA approval lowers, but doesn’t eliminate disparities in immunotherapy use

    Racial, ethnic and sociodemographic disparities that are present in clinical trials and compassionate use agreements for cancer immunotherapy during the pre-approval period are reduced, but not eliminated after the US Food and Drug Administration (FDA) approves these cancer treatments, according to recent research published in JAMA Network Open .   “The time frame leading up to FDA approval is an important period in which to observe disparities,” Theresa Ermer, MD, of...