Presentation
MDD7 - Device delivery developer support to pharmaceutical companies for Abbreviated New Drug Application (ANDA) Submission of Drug-Device combination product
DescriptionIn January of 2017, a draft guidance was prepared by the FDA entitled, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product submitted in an ANDA: Draft Guidance for Industry.
This presentation is a case-study, presenting how Device Delivery Developer can help de-risking pharmaceutical companies’ ANDA submission for their final combination product by performing comparative analysis & Comparative use Human Factors formative studies.
1. As defined in the above FDA guidance, a threshold analysis is a comparison between a generic drug-device combination product and its RLD, looking at 3 aspects:
• The side by side labelling comparison
• The comparative task analysis
• The physical device comparison
As an example, as a first support level to pharmaceutical companies, Delivery Device Developer can assess, drug independently, 2 of the 3 aspects of a threshold analysis (labeling comparison being drug dependent):
• The comparative task analysis
• The physical device comparison of constituent parts
This first assessment will give a first overview of the potential design differences and associated risks. This also provide first risk mitigation thanks to litterature review.
After assessments of outcomes, if ‘Other design difference’ are highlighted, the need to perform a final CUHF study with final combined product is determined, as requested by the FDA guidance : If ‘Other differences’ are deemed significant, FDA may request that applicants provide additional information and/or data, such as data from a comparative use human factors study (CUHF), to address whether the differences identified in the user interface introduce a risk that might impact the clinical effect or safety profile of the generic combination product as compared to the RLD.
This CUHF study is a non-inferiority study where statistical significance needs to be demonstrated.
But how to set objectives, margin d, sample size as requested by the FDA?
2. To reinforce its support to pharmaceutical companies, Delivery Device Developer can build formative comparative use human factors study with generic device filled with placebo to assess the user error rates of the generic device and its corresponding RLD. This formative study performed on a low number of users (i.e. 5-8 participants per user group) is not intended to replace the final CUHF study to be done with final finished combination product, but to get insight on the use error rate, the within subject correlation allowing to calculate the sample size and margin d that will be used as a basis by pharmaceutical companies to conduct their final CUHF study with final combined product.
3. Example: BD Vystra™ Disposable Pen
These results and Becton Dickinson supportive approach will be shared on the poster.
This presentation is a case-study, presenting how Device Delivery Developer can help de-risking pharmaceutical companies’ ANDA submission for their final combination product by performing comparative analysis & Comparative use Human Factors formative studies.
1. As defined in the above FDA guidance, a threshold analysis is a comparison between a generic drug-device combination product and its RLD, looking at 3 aspects:
• The side by side labelling comparison
• The comparative task analysis
• The physical device comparison
As an example, as a first support level to pharmaceutical companies, Delivery Device Developer can assess, drug independently, 2 of the 3 aspects of a threshold analysis (labeling comparison being drug dependent):
• The comparative task analysis
• The physical device comparison of constituent parts
This first assessment will give a first overview of the potential design differences and associated risks. This also provide first risk mitigation thanks to litterature review.
After assessments of outcomes, if ‘Other design difference’ are highlighted, the need to perform a final CUHF study with final combined product is determined, as requested by the FDA guidance : If ‘Other differences’ are deemed significant, FDA may request that applicants provide additional information and/or data, such as data from a comparative use human factors study (CUHF), to address whether the differences identified in the user interface introduce a risk that might impact the clinical effect or safety profile of the generic combination product as compared to the RLD.
This CUHF study is a non-inferiority study where statistical significance needs to be demonstrated.
But how to set objectives, margin d, sample size as requested by the FDA?
2. To reinforce its support to pharmaceutical companies, Delivery Device Developer can build formative comparative use human factors study with generic device filled with placebo to assess the user error rates of the generic device and its corresponding RLD. This formative study performed on a low number of users (i.e. 5-8 participants per user group) is not intended to replace the final CUHF study to be done with final finished combination product, but to get insight on the use error rate, the within subject correlation allowing to calculate the sample size and margin d that will be used as a basis by pharmaceutical companies to conduct their final CUHF study with final combined product.
3. Example: BD Vystra™ Disposable Pen
These results and Becton Dickinson supportive approach will be shared on the poster.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives