Featured Editorial

  1. 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.

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 This article shares the 13 key takeaways, including differences from the draft guidance.

  3. 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.

  4. 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.

  5. Oral Solid Dosage Formulation And Process Development: A Case Study 12/4/2024

    This case study involves a drug substance currently in the preclinical phase. Discussion includes API physical chemical characteristics, enabling technologies, formulation assessment, and more.

  6. 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.

  7. Enteric Coatings For Oral Solid Dosages: A Short Guide 11/19/2024

    Enteric coatings play a pivotal role for drugs/APIs that need to withstand the harsh conditions of the stomach in order to dissolve in the intestine. This article shares an overview, commonly used excipients, and more.

  8. 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.

  9. 5 Areas Of Drug Delivery Innovation To Watch In 2025 11/12/2024

    2024 has seen some promising advances in drug delivery technology. Strategic pharma/biotech companies may wish to seize these opportunities for their drug candidates in 2025.

  10. How Does Robotics Aid Occlusion Testing For Drug Delivery Devices? 11/5/2024

    Robotic automation simulates, detects, and resolves occlusions under controlled conditions for drug delivery systems such as infusion pumps, catheters, IV lines, and insulin pumps.