Featured Editorial

  1. A Cost-Effective Approach To EU MDR Compliance 4/2/2024

    How can you be cost-effective in the face of the cost of compliance with the EU's Medical Device Regulation (MDR)? This article shares tips.

  2. Eying Up The Era Of Topical Biologics 3/19/2024

    Claris Bio’s phase 1/2 clinical trial in patients with Stage 2 or 3 Neurotrophic Keratitis (NK) is breaking new ground in the development of topically administered biologic therapies. 

  3. Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification 3/19/2024

    This article dispels the myth that obtaining EU MDR certification is an end point. The evolving landscape demands ongoing diligence to comprehend and adhere to changing requirements.

  4. Super Generics: Market Trends In Europe 3/12/2024

    Super generics combine advanced formulations and delivery methods, and improved bioavailability, compared to traditional generics. This article shares market research trends in the market in Europe.

  5. New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis 2/29/2024

    On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.

  6. Exploring Biolistic Particle Delivery Systems 2/29/2024

    The main objective of biolistic particle delivery is to insert genetic material or other molecules into cells or tissues for diverse applications, including genetic engineering, gene therapy, and plant modification. The ability to target substances into specific cells enables researchers to investigate gene functionality, alter genetic traits, or explore novel therapeutic strategies.

  7. Use-Related Risk Analysis For Combination Products 2/7/2024

    One of the most integral components in the development of drug-device combination products is the use-related risk analysis (URRA) and its applicability to the overall human factors engineering process. Deficiencies in the URRA are a leading cause of delays with FDA submissions.

  8. Foundational Human Factors Engineering Concepts For The Design Of Combination Products 2/5/2024

    How can companies keep pace with the demand in the combination products market while meeting or exceeding regulatory expectations of applying human factors engineering? This article provides an overview.

  9. Osmotic Controlled Release Oral Drug Delivery: A Closer Look 2/2/2024

    Osmotic controlled release drug delivery is not often spoken about, but it is a useful oral drug formulation technology. This article shares the mechanisms of the elements of oral dosage, including the semi-permeable membrane, pore-forming agents, and more, as well as advantages and applications of this type of drug delivery.

  10. Auto-injectors: Global Trends & Market Forecast 1/30/2024

    Auto-injectors offer a dependable method for delivering medication, especially during emergency scenarios. This article shares new market research, including macro trends, smart features, disposable vs. reusable trends, and more.