• Regulatory NewsRegulatory News

    FDA elevates OTAT to “Super Office” within CBER

    The US Food and Drug Administration (FDA) announced this week it has elevated and reorganized its Office of Tissues and Advanced Therapies (OTAT) to a “Super Office” within the Center of Biologics Research and Evaluation (CBER) to meet its growing workload and new commitments under the Prescription Drug User Fee Act (PDUFA VII) agreement for FY2023-2027.   The office will be renamed the Office of Therapeutic Products (OTP).   “With the current and anticipated incre...
  • Feature ArticlesFeature Articles

    Nutrition and health claims in the European Union in 2022

    Nutrition and health claims are widely used on food labels and may positively influence consumer perceptions and intentions to buy food. Regulation (EC) 1924/2006 on nutrition and health claims aims to ensure claims are clear, scientifically substantiated, and supports consumers to make informed decisions. The European Commission (EC) is working to introduce a legislative proposal on nutrient profiles in 2022 to restrict the use of claims on foods high in saturated fat, su...
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    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...
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    Getting ready for the FDA’s upcoming QMSR

    The FDA’s Quality Management System Regulation (QMSR) proposal, paired with the International Organization for Standardization’s ISO 13485:2016, is expected to deliver cost savings to medtech organizations that adhere to both requirements. This article covers the differences between QMSR, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP) so leaders can prepare for the upcoming changes.    Keywords – MDSAP, quality management, quality system regulat...
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    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...
  • 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) ...
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    Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition

    Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...
  • Feature ArticlesFeature Articles

    An update of China’s food safety regulatory framework

    This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formula, health foods (functional foods), and food for special medical purposes (FSMP). Keywords – infant formula; food for special medical purposes; food regulatory control; food safety; food standards   Introduction Since the m...
  • 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 ...
  • Regulatory NewsRegulatory News

    FDA explains when it will rescind breakthrough designations

    The US Food and Drug Administration (FDA) on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy designation (BTD) during its evaluation of a drug.   While FDA has long asserted its authority to rescind or withdraw BTDs, the new guidance will add clarity for sponsors as to when the agency might revoke the designation. Since designation was created under the Food and Drug Administration Safety and Innovation Act in 2012,...
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    Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests

    Peter Marks, director of Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), attributes an increase in the amount of regenerative medicine advanced therapy (RMAT) requests approved for cell and gene therapies to sponsors “getting the hang” of the agency’s expectations for designation requests.   Marks spoke at the California Separation Science Society’s (CASSS) meeting on 8 June on cell and gene therapies. The meeting was h...
  • Regulatory NewsRegulatory News

    FDA explains plans to bolster cell and gene therapy approvals through wider messaging

    Updated 25 May 2022 to correct ASGCT's name. Wilson Bryan director of the US Food and Drug Administration’s Office of Tissues and Advanced Therapies (OTA) in the agency’s Center for Biologics Evaluation and Research, told a 19 May meeting  of the American Society of Gene and Cell Therapy (ASGCT) that the division is undertaking a series of internal measures to improve communications with sponsors and to widen its messaging.   These measures are being taken to com...