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  • Feature ArticlesFeature Articles

    Latin America market opportunities for food supplements: Navigating regulatory complexities

    This article discusses the growth opportunities in Latin America for food supplement businesses. It provides guidance for companies eager to interpret current regulation, predict future direction, and plan successful commercial strategies. The author addresses the commercial advantages going along with increased regional and global harmonization and how to navigate current regulatory complexities to realize commercial opportunities and meeting the challenges and opportunit...
  • Regulatory NewsRegulatory News

    FDA Flags Incidents of Excess Radiation Exposure to Patients

    The US Food and Drug Administration (FDA) imposed a boxed warning on the labeling of rubidium 82 generators, which are used with Positron Emission Tomography (PET) heart perfusion imaging scans. The agency circulated the drug safety alert on Monday in response to recent excess radiation exposure incidents. Manufacturers Bracco Diagnostics and Jubilant DraxImage also sent letters last month to inform health care providers about incidents of patients’ exposure to high lev...
  • Regulatory NewsRegulatory News

    FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products

    A little more than a year after pushing back the date by which combination product companies must comply with certain postmarket safety reporting (PMSR) requirements, the US Food and Drug Administration (FDA) on Tuesday extended the compliance deadline again. The updated guidance explains how FDA does not intend to enforce 21 CFR 4.102(c) and (d) (constituent part-based PMSR requirements), 4.104(b)(1) and (b)(2) (submission process for constituent part-based Individual ...
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    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    Australia Unveils Device Action Plan

    Australia’s Therapeutic Goods Administration (TGA) released a three-part medical device action plan, part of which will make adverse event reports more timely, as well as enhance public awareness on and the agency and device regulatory system. The plan also identifies additional opportunities for TGA to increase transparency, with stakeholder consultations on proposed changes to regulatory requirements and forthcoming guidance materials. Until early 2020, potential c...
  • Regulatory NewsRegulatory News

    Q&A: Why Seven Regulators Use One Company’s Software for Drug and Biologics Reviews

    To streamline decision-making in approval processes, three regulatory authorities joined four others Thursday in increasing their adoption of drug development consultancy Certara’s Phoenix platform. The UK’s Medicines and Healthcare products Agency (MHRA), Brazil’s National Health Surveillance Agency (ANVISA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA) are now licensing Certara’s Phoenix IVIVC toolkit for in vitro-in vivo correlation. The agencies wer...
  • Regulatory NewsRegulatory News

    FDA’s De Novo Program Gains Momentum

    The US Food and Drug Administration (FDA) has been steadily increasing the annual number of granted de novo classification requests in recent years and hit a record of 44 de novos granted during 2018. The de novo premarket review pathway, used for novel, low-to-moderate-risk devices that are not substantially equivalent to already marketed devices, has increasingly attracted interest in the medical device ecosystem, particularly after the quick turnaround for Apple’s g...
  • Regulatory NewsRegulatory News

    FDA Panel Recommends New Postmarket Requirements for Breast Implants

    As part of efforts to make breast implants safer, the US Food and Drug Administration (FDA) should consider additional postmarket data reporting requirements on breast implant manufacturers, the agency’s General and Plastic Surgery Devices Panel suggested after a two-day meeting. On whether to remove textured breast implants from the US market as other countries have done, the panel argued data is lacking to support such a recommendation as it would reduce options for p...
  • Regulatory NewsRegulatory News

    FDA, DHS Alert to Cybersecurity Flaws Affecting Medtronic Cardiac Devices, Programmers, Monitors

    Hundreds of thousands of units of Medtronic implantable cardiac devices, programmers and home monitors are vulnerable to cybersecurity incidents, according to two US federal government notices. On Thursday, the US Food and Drug Administration (FDA) issued an FDA safety communication, while the US Department of Homeland Security's (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory to flag cybersecurity vulnerabilities detected in...
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    FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures

    Patients and health care providers should know that the safety and effectiveness of robotically-assisted surgical devices for the prevention or treatment of cancer has not been established for use in the US, a US Food and Drug Administration (FDA) safety communication warned on Thursday. The safety communication urges caution when using robotically-assisted surgical devices for mastectomy and any other cancer-related surgery, citing the lack of FDA evaluation on use of ...
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    FDA Alerts on Increased Risks Linked to Pfizer’s Xeljanz

    The US Food and Drug Administration (FDA) alerted the public late Monday of a post-marketing safety clinical trial for Xeljanz (tofacitinib) that found an increased risk of lung blood clots and death in patients with rheumatoid arthritis (RA) who were taking a dose of 10 mg twice daily. The drug safety communication noted the increased risk was observed in the post-marketing trial set as a requirement on Pfizer following the first approval  of Xeljanz in 2012. It comes...
  • Regulatory NewsRegulatory News

    Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma

    Swissmedic said Monday that based on the currently available information, the association Swiss Plastic Surgery recommends using smooth implants rather than textured implants where permitted by the clinical situation. France’s National Agency of Medicine and Health Products (ANSM) echoed that recommendation after observing most known breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases in patients with textured breast implants. But the committee doe...