Featured Editorial

  1. A Critical Analysis Of FDA Human Factors IFU Guidance For Drug Delivery Devices 5/8/2024

    Drug administration by lay users is becoming more common. Is current FDA guidance viable for demonstrating safe and effective use for critical devices and systems? No.

  2. How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint 4/29/2024

    EU MDR has raised the bar compared to other jurisdictions in areas such as stronger emphasis on collecting pre- and post-market data. If you align your operating model for EU compliance, you'll be in a better position to enter other markets.

  3. Long Live Design Controls: Navigating The Shift From QSR To QMSR 4/22/2024

    The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.

  4. Organizational Imperatives For Combination Product Development 4/18/2024

    Developers of combination products must address varied and numerous regulatory stipulations and considerations. In this article, drug delivery industry veteran Fran DeGrazio offers recommendations for how to do so efficiently and effectively.

  5. The EU's Ban On TiO2 In Food May Impact Pharma. Here's What You Should Know. 4/18/2024

    Titanium dioxide (TiO2) is used as a food additive and OSD pharmaceutical excipient. In 2020, the European Food Safety Authority noted data gaps regarding particle size, which can affect its toxicological properties, so the European Commission banned it as a food additive. Here's how this could impact pharma.

  6. Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms 4/16/2024

    Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.

  7. A Promising Approach To Develop An Inhalable, Temperature-Stable COVID-19 Vaccine 4/12/2024

    There are limitations to the currently available COVID-19 vaccines. An inhalable dry powder approach offers promising benefits, such as eliminating cold chain requirements, allowing for more widespread immunity.

  8. Understanding The New MHRA Requirements For Medical Devices In Great Britain 4/9/2024

    The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance.

  9. A Holistic Approach To Your Medical Device's Usability 4/8/2024

    Medical device developers must plan and design for what happens once their device leaves the manufacturing facility. Consider how a device will make the journey to its intended users and how those users will work with the device.

  10. Breaking Through The Blood–Brain Barrier: The Rise Of Focused Ultrasound 4/5/2024

    Focused ultrasound can noninvasively, safely, and reversibly open the blood–brain barrier, overcoming a major obstacle for therapies targeting neurodegenerative diseases. Here's how.