The draft guidance calls for sponsors of new drug and biologics license applications to apply population PK analysis, which is frequently used to guide drug development on therapeutic individualization.
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.
Not only must new IoMT patents make it through the typical granting process, the market’s size suggests that post-grant challenges may become increasingly common.
It is critical that companies in the medical device space have comprehensive, well-written, and descriptive procedures not only for documentation, but for assessing the impact of any and all changes, no matter how minor.
The guidance looks at what constitutes a manufacturing site change, when a manufacturer should submit a PMA supplement, what documentation should be submitted to the FDA with a site change supplement, and more.
This article examines a report issued by the Office of the Inspector General of the Department of Health and Human Services, resultant of an audit of the FDA’s internal processes to ensure cybersecurity in the postmarket phase of medical devices – as well as the FDA’s disagreements with the findings and what this means for manufacturers going forward.
Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.
The “messy, getting started” period in pre-product development can make many development teams and life science organizations uncomfortable – until you recognize “fuzzy” as less of a warning, and more of an invitation.
To fully realize the potential of bioelectronic medicine, medical device developers will need to find ways to move beyond “set and forget” biostimulation devices to closed-loop systems that can provide more responsive and personalized treatments.