Transdermal Drug Delivery Articles
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Embrace Packaging and Delivery Systems Designed for Today's Standards
7/1/2024
Regulations and standards for drug delivery systems and packaging are ever evolving and expanding, making it harder and more costly for older products to meet them. In this article, Fran DeGrazio explains why it is imperative that pharma companies consider new product adoption.
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The Key to Regulatory Innovation? Global Harmonization
6/4/2024
Innovation in drug development and delivery is often thought of as purely a technical matter. In this article, Fran DeGrazio illustrates why innovation must also be applied to regulatory practices.
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Balancing Sustainability With Patient Safety In Medical Device Design
6/3/2024
There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.
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Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies
5/24/2024
The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.
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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.
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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The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.
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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.
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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.
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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.
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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.