Featured Editorial

1. Only DTx In Drug Delivery Can Take Us To The Next Level Of Diabetes Care 1/8/2025

   The convergence of advanced technologies and advancements in drug delivery is reshaping diabetes care. Digital therapeutics (DTx) deliver therapeutic interventions driven by high-quality software and mobile applications.

2. U.S. Deregulation During The Trump Administration: Opportunities And Challenges For The Global Medical Device Industry 1/3/2025

   The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA as a focal point for deregulation. What does this mean for medical device companies?

3. 5 Reasons Why 2025 Is The Year Pharma Companies Will Revisit Their Drug Delivery Device Strategies 1/2/2025

   2025 will be the year for pharmaceutical companies to revisit their drug delivery device strategies or risk being left behind. Here are the five reasons why.

4. Drug Delivery Outlook: 7 Waves To Ride In 2025 And Beyond 12/30/2024

   With a view of the evolving landscape of health policy and patient needs, Fran DeGrazio identifies seven biopharmaceutical industry trends that should drive innovation and practical implementation in drug delivery. Harmonization, digitization, quality, intelligence, and agility are among the focus areas Fran recommends for forward-thinking biopharmaceutical companies. 

5. 9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond 12/17/2024

   Current challenges in Europe's medical device market include the EU MDR transition and a lack of harmonization. Device manufacturers, regulators, and other stakeholders can take these key actions to create positive change.

6. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

   ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

7. The 5 Major Regulatory Focus Areas For Medical Device Compliance In 2025 12/10/2024

   Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be preparing.

8. Decoding The FDA's Final Guidance On PCCPs For AI-Enabled Device Software Functions 12/9/2024

   In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions. This article shares the 13 key takeaways, including differences from the draft guidance.

9. How Atsena Got Its Gene Therapy To Spread Subretinally To Treat XLRS 12/6/2024

   The company’s novel capsid, part of a Phase 1/2 trial, is delivering therapeutic genes to the fovea without the need for detaching part of the retina.

10. How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies? 12/5/2024

    FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.