Transdermal Drug Delivery Articles

1. 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?

2. 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.

3. 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. 

4. 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.

5. 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.

6. 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.

7. 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 This article shares the 13 key takeaways, including differences from the draft guidance.

8. 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.

9. 5 Top-Of-Mind Drug Delivery Topics In 2024 12/3/2024

   In this article, Fran DeGrazio highlights five drug delivery challenges that were commonly discussed by industry insiders throughout 2024. With particular focus on combination products, these key themes included supplier qualification, cross-functional product development, platform approaches, patient self-administration, and regulatory considerations.

10. We're Heading Toward A Bottleneck For EU MDR Approvals; How To Get Ahead 11/13/2024

    The EU Commission had issued an extension to manufacturers to sign up with a notified body for EU Medical Devices Regulation (MDR) compliance, but instead, manufacturers have slowed down compliance activities, resulting in an upcoming bottleneck of approvals.