The new EU draft guidance Guideline on the quality requirements for drug-device combinations and U.S. draft guidance Principles of Premarket Pathways for Combination Products are the latest attempts by each body to adequately regulate combination products. In this two-part series, we examine the two guidances in detail, starting with the U.S. guidance.
This is the first article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules.
Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.
Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.
The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.
Support services must be designed to attract and benefit patient and provider targets. Thoughtful consideration and planning must drive patient access and uptake, and mechanisms need to be implemented to evaluate effectiveness.
Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.
The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.
The Medical Device Single Audit Program (MDSAP) has worked out its kinks and is poised for exponential growth, but it may be a while before the initiative makes headway in the EU and China.
Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.
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