• Regulatory NewsRegulatory News

    FDA finalizes guidance on food effect studies, issues draft on contamination prevention for non-penicillin beta-lactam drugs

    The US Food and Drug Administration (FDA) recently issued two guidances for industry: a final guidance on how to conduct food effect studies for oral drugs being considered for investigational new drug (IND) and new drug applications (NDAs), and a draft guidance outlining a current good manufacturing practice (CGMP) framework for preventing penicillin from cross contaminating non-penicillin beta-lactam drugs and compounds. Food effect studies   The final guidance on...
  • ReconRecon

    Recon: FDA signals support for updated COVID vaccines; EMA recommends BioMarin’s hemophilia gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel to advise on whether — and how — Covid vaccines should be updated ( STAT ) ( NYTimes ) ( Endpoints ) ( Fierce ) Pfizer/BioNTech say Omicron-based COVID shots improve response vs that variant ( Reuters ) FDA places partial clinical hold on David Hung biotech after certain cancer patients experience eye inflammation ( Endpoints ) Astellas’ gene therapy...
  • 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

    Evolution of the Japanese regulatory system and agencies

    The Japanese regulatory system has been recognized as one of the most sophisticated and stringent regulatory systems in the world. The regulatory policies are developed and administered by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) executes the policies, and certain authorities are delegated to local governments. Over the last 6 decades, the Japanese regulator has faced many challenges but has kept enhancing the...
  • RF Quarterly

    China’s NMPA: The evolution of medical device regulation

    This article describes the main changes of China's drug and device regulatory system in the past 70 years, with the focus on medical devices rather than drugs. The article highlights the latest changes in the regulation of medical devices and examines international cooperation in the field of medica devices and the regulatory framework for the medical device product life-cycle in China. It also includes the latest updates for medical device regulation in 2022 and beyond. ...
  • RF Quarterly

    The ICH over the last 30 years: A personal reflection

    This article gives a personal reflection on the development of ICH since its inception in 1990 and during which time the author was involved both as a regulator and, more recently, an industry participant. The evolution of ICH is discussed as it has moved from an international organization involving three regions to a truly global body. The successes and the challenges are discussed, and consideration is given to future development.   Keywords – international harmo...
  • RF Quarterly

    The history of clinical trial disclosure

    The scope and complexity of requirements for global clinical trial disclosures and data sharing have increased substantially over the last 20 years. Most leading countries have specific regulations pertaining to trial conduct, and many have set up patient registries for collecting and analyzing data on patient outcomes. More recently, authorities have initiated inspections relating to disclosure to ensure compliance with regulations, and transparency advocates continue to ...
  • 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) ...
  • 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 ...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Spring regulatory agenda, upcoming guidances, 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, we get a glimpse at FDA’s Spring regulatory agenda and get tips on several upcoming guidances. Plus, we learn about a new 510(k) pilot program for CBER-regulated medical devices.   Next week, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will ...
  • Regulatory NewsRegulatory News

    FDA to form task force, public-private partnership on rare neurodegenerative diseases

    The US Food and Drug Administration (FDA) released a five-year action plan for accelerating drug development for rare neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS), as well as improving access to novel therapies.   “The effects of rare neurodegenerative diseases are devasting, with very few effective therapeutic options available to patients,” Robert M. Califf, MD, FDA Commissioner, said in a statement. “This action plan, especially including ...
  • TrackersTrackers

    COVID-19 vaccine tracker

    In March 2020, the Regulatory Focus editorial team was eager to find a way to meet the information needs of RAPS members and the regulatory community as the reality of a coronavirus pandemic set in. Guided by the RAPS Editorial Advisory Committee, the first iteration of this tracker was published on 21 March 2020.    What started as a running list containing one Phase I vaccine candidate (now known as Moderna’s Spikevax) and scores of preclinical possibilities evol...