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  • Regulatory NewsRegulatory News

    ICH releases widely anticipated guidance on continuous manufacturing

    The International Council for Harmonisation (ICH) on Tuesday issued its Q13 guideline on continuous manufacturing, making a draft available for public comment.   The long-awaited draft was soon expected, according to an FDA official who gave an update on the status of the guideline at a 14 July CMC Strategy Forum sponsored by the California Separation Science Society (CASSS). (RELATED: Long-awaited ICH continuous manufacturing guideline coming soon , Regulatory Foc...
  • Regulatory NewsRegulatory News

    Long-awaited ICH continuous manufacturing guideline coming soon

    The International Council for Harmonization (ICH) Q13 guideline on continuous manufacturing is expected to be released for public comment soon, as the US pharmaceutical industry continues slow but steady adoption of this mode of manufacturing.   Cyrus Agarabi, a reviewer in FDA’s Office of Biotechnology Products in the Office of Pharmaceutical Quality, updated attendees on the status of the ICH Q13 guideline at the 14 July CMC Strategy Forum sponsored by the California...
  • Regulatory NewsRegulatory News

    EMA guidelines highlight changes to IMPs triggering notification to regulators

    The European Medicines Agency (EMA) on 1 July released for public consultation two draft guidelines to help sponsors of investigational medicinal products (IMPs) for new drugs and biologics decide whether manufacturing changes are considered a “substantial modification” needing prior approval.   These guidelines are connected to the EU regulation No. 536/2014 which came into force on 20 June 2014. The regulation defines a “substantial modification” as any change to a...
  • Regulatory NewsRegulatory News

    FDA focuses on efforts made to avert drug shortages in 2020

    New drug shortages in the US decreased in 2020, in part because of the US Food and Drug Administration’s (FDA’s) use of enforcement discretion to ensure an uninterrupted supply of critical medical products during the COVID-19 public health crisis.   Yet, the agency’s new drug shortages report to Congress said that while these actions helped avert shortages in the short-term, more work is needed to improve supply chain resiliency.   This report summarizes the agency...
  • Regulatory NewsRegulatory News

    FDA issues final guidance on CMC postapproval changes for biologics

    The US Food and Drug Administration (FDA) on Monday issued a final guidance to assist manufacturers of biological products in determining which types of changes to their products should be submitted in an annual report and which will require a prior approval supplement, the highest reporting category.   The guidance contains minor changes from a draft issued in December 2017; no reporting changes were switched from the minor to major category. Licensed biological produ...
  • Feature ArticlesFeature Articles

    Strategic lifecycle approach to medical device regulation

    The purpose of this article is to highlight new facets of EU Medical Device Regulation (MDR) in the medical device industry. The article contains references to both MDR legal articles and recommendations that will challenge organizations to take a more holistic viewpoint of their products, resources, and regulatory toolkit to be compliant in the EU.   Introduction The application date of 2017/745 MDR 1 is 26 May 2021, when it will officially supersede the 93/42/EC...
  • Regulatory NewsRegulatory News

    Legislators blast Emergent officials at House hearing

    Members of the US House of Representatives lambasted officials of Emergent BioSolutions for ignoring serious potential contamination and cleanliness problems at their facility, causing millions of COVID-19 vaccine doses to be thrown out.   The House Select Subcommittee on the Coronavirus Crisis, chaired by Rep. James Clyburn (D-SC) along with the House Committee on Oversight and Reform heard testimony from Robert Kramer, president and chief executive officer of Emerge...
  • Regulatory NewsRegulatory News

    FDA finds mess of sterility problems at Emergent

    Officials from the US Food and Drug Administration (FDA) urged Emergent BioSolutions to stop producing vaccines until it corrects a litany of unsafe practices at the plant which compromised the quality of products. These problems were identified following a recent inspection of the plant’s facility in Baltimore.   The company was contracted by Johnson & Johnson to manufacture its COVID-19 vaccine but had to throw out 15 million doses recently due to a mix-up of ingredi...
  • Regulatory NewsRegulatory News

    Federal officials design new mask guidelines to better protect more workers

    Federal officials announced new measures to help get fresh, new N95 masks to health care workers and expand their use in other industries after scientists argued that the highly protective masks are essential to keep workers safe from covid-19. The changes come as US mask-makers say the demand from hospitals is so sluggish that they’ve laid off 2,000 workers and fear some new protective gear companies could collapse. Yet in a letter to lawmakers, hospitals cite ongoing c...
  • Feature ArticlesFeature Articles

    Communication of regulatory intelligence: A survey of the medical device industry

    Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets, where medical device regulations can change rapidly or be confusing and even contradictory. Understanding how, when, and with whom to communicate the new or changing regulatory information within a medical device company affects global market strategy and product success. The research reported here examined how medical device companies structure their regulatory i...
  • Regulatory NewsRegulatory News

    MCIT: Not a better way to pay for breakthrough devices

    The Medicare Coverage of Innovative Technology (MCIT) pathway should be rescinded because it does not require thorough evidence of the safety and efficacy of the medical device for which it aims to provide coverage, Vinay K. Rathi, MD, of Harvard Medical School and colleagues wrote in a perspective published in the New England Journal of Medicine .   MCIT would provide up to four years of Medicare coverage for medical devices authorized under the US Food and Drug Admi...
  • Feature ArticlesFeature Articles

    Transforming regulatory strategy to meet the evolving compliance landscape

    Changes in industry regulations are now viewed as one of the top three disruptive business trends facing pharmaceutical and life sciences organizations today. These same pressures are extending to the medical device market. In this article, the authors explore how perception of regulatory compliance is evolving due to a variety of driving forces. They outline the role digital transformation can play in helping pharmaceutical companies meet new regulatory compliance demands...