Research graph
References from Approval lag and loss for biologic-device combination products in Japan and the United States. Local targets link to admitted publications; unresolved targets remain external evidence.
Delays in new drug applications in Japan and industrial R&D strategies
10.1038/clpt.2009.215 · 2010 · External reference
Different development strategies affecting Japan’s drug lag between Japan-based and foreign-based companies
10.1007/s43441-024-00649-y · 2024 · External reference
An empirical analysis of Japan’s drug development lag behind the United States
10.1002/jcph.2023 · 2022 · External reference
Potential future drug development lag in Japan based on an analysis of multiregional clinical trials in the US, Europe, and East Asia
10.1007/s43441-022-00381-5 · 2022 · External reference
Lag time for new innovative, first-in-class drug approval in Japan
10.1248/bpb.b21-00898 · 2022 · External reference
Consideration of the biosimilar drug lag and loss among Japan, the USA, and the EU
10.1007/s00210-025-04494-0 · 2026 · External reference
Unresolved reference
2024 · External reference
Analysis of factors contributing to drug lag and drug loss from an industry perspective and the need for public-private co-creation
10.14982/rsmp.16.79 · 2026 · External reference
Regulatory framework for drug-device combination products in the United States, Europe, and Korea
10.1007/s43441-024-00661-2 · 2024 · External reference
The concizumab pen-injector is easy to use and preferred by hemophilia patients and caregivers: a usability study assessing pen-injector handling and preference
10.2147/ppa.s470091 · 2024 · External reference
Significance of self-injectable biologics in Japanese patients with severe allergic diseases: focusing on pen-type devices and copayment
10.2147/ppa.s430038 · 2023 · External reference
Understanding and minimising injection-site pain following subcutaneous administration of biologics: a narrative review
10.1007/s40744-020-00245-0 · 2020 · External reference
Unresolved reference
External reference
Unresolved reference
2024 · External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
External reference
Unresolved reference
2026 · External reference
Recent trends in the approval review of medical devices
10.2530/jslsm.30.55 · 2009 · External reference
Issues surrounding the development and review of medical devices
10.4091/iken.19.51 · 2009 · External reference
Definition of the device lag and its measurement
10.4286/jjmi.79.273 · 2009 · External reference
Unresolved reference
2014 · External reference
Japan Unveils 5-year plan to boost clinical research
10.1016/s0140-6736(07)60615-1 · 2007 · External reference
Follow the leader
10.1038/453851a · 2008 · External reference
From drug lag to drug loss in Japan: challenges and initiatives focusing on pediatrics and rare diseases
10.14982/rsmp.16.59 · 2026 · External reference
Comparison of approval timing and changing process of labels of three new innovative antibody medicines originated in Japan with those of FDA and EMA
2018 · External reference
Future regulatory science through a global product development strategy to overcome the device lag
10.1248/yakushi.15-00224-2 · 2016 · External reference
Trends in the market for drug delivery devices categorized as combination drugs and medical devices and regulatory challenges for autoinjectors in Japan
10.3389/fmedt.2024.1461460 · 2024 · External reference
Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics
10.1080/19420862.2017.1392424 · 2018 · External reference
A review of recent FDA-approved biologic-device combination products
10.1016/j.xphs.2023.12.022 · 2024 · External reference
Overcoming barriers to patient adherence: the case for developing innovative drug delivery systems
10.1038/s41573-023-00670-0 · 2023 · External reference
A survey on medicine adoption and appropriate use in hospitals in 2020
10.11256/jjdi.25.12 · 2023 · External reference
Recent advancements in pharmaceutical packaging and regulatory aspects
10.1007/s41783-024-00179-w · 2025 · External reference
The adherence and outcomes benefits of using a connected, reusable auto-injector for self-injecting biologics: a narrative review
10.1007/s12325-023-02671-2 · 2023 · External reference
New visualization models of designation pathway and group categorization of device-drug and device-biologic combination products classification in the United States: analysis of FDA capsular decisions
10.1007/s43441-021-00276-x · 2021 · External reference
An empirical analysis of Japan’s drug development lag behind the United States
10.1002/jcph.2023 · ExternalCitation · doi-reference
Consideration of the biosimilar drug lag and loss among Japan, the USA, and the EU
10.1007/s00210-025-04494-0 · ExternalCitation · doi-reference
The adherence and outcomes benefits of using a connected, reusable auto-injector for self-injecting biologics: a narrative review
10.1007/s12325-023-02671-2 · ExternalCitation · doi-reference
Understanding and minimising injection-site pain following subcutaneous administration of biologics: a narrative review
10.1007/s40744-020-00245-0 · ExternalCitation · doi-reference
Recent advancements in pharmaceutical packaging and regulatory aspects
10.1007/s41783-024-00179-w · ExternalCitation · doi-reference
New visualization models of designation pathway and group categorization of device-drug and device-biologic combination products classification in the United States: analysis of FDA capsular decisions
10.1007/s43441-021-00276-x · ExternalCitation · doi-reference
Potential future drug development lag in Japan based on an analysis of multiregional clinical trials in the US, Europe, and East Asia
10.1007/s43441-022-00381-5 · ExternalCitation · doi-reference
Different development strategies affecting Japan’s drug lag between Japan-based and foreign-based companies
10.1007/s43441-024-00649-y · ExternalCitation · doi-reference
Regulatory framework for drug-device combination products in the United States, Europe, and Korea
10.1007/s43441-024-00661-2 · ExternalCitation · doi-reference
A review of recent FDA-approved biologic-device combination products
10.1016/j.xphs.2023.12.022 · ExternalCitation · doi-reference
Japan Unveils 5-year plan to boost clinical research
10.1016/s0140-6736(07)60615-1 · ExternalCitation · doi-reference
Follow the leader
10.1038/453851a · ExternalCitation · doi-reference
Delays in new drug applications in Japan and industrial R&D strategies
10.1038/clpt.2009.215 · ExternalCitation · doi-reference
Overcoming barriers to patient adherence: the case for developing innovative drug delivery systems
10.1038/s41573-023-00670-0 · ExternalCitation · doi-reference
Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics
10.1080/19420862.2017.1392424 · ExternalCitation · doi-reference
A survey on medicine adoption and appropriate use in hospitals in 2020
10.11256/jjdi.25.12 · ExternalCitation · doi-reference
Lag time for new innovative, first-in-class drug approval in Japan
10.1248/bpb.b21-00898 · ExternalCitation · doi-reference
Future regulatory science through a global product development strategy to overcome the device lag
10.1248/yakushi.15-00224-2 · ExternalCitation · doi-reference
From drug lag to drug loss in Japan: challenges and initiatives focusing on pediatrics and rare diseases
10.14982/rsmp.16.59 · ExternalCitation · doi-reference
Analysis of factors contributing to drug lag and drug loss from an industry perspective and the need for public-private co-creation
10.14982/rsmp.16.79 · ExternalCitation · doi-reference
Significance of self-injectable biologics in Japanese patients with severe allergic diseases: focusing on pen-type devices and copayment
10.2147/ppa.s430038 · ExternalCitation · doi-reference
The concizumab pen-injector is easy to use and preferred by hemophilia patients and caregivers: a usability study assessing pen-injector handling and preference
10.2147/ppa.s470091 · ExternalCitation · doi-reference
Recent trends in the approval review of medical devices
10.2530/jslsm.30.55 · ExternalCitation · doi-reference
Trends in the market for drug delivery devices categorized as combination drugs and medical devices and regulatory challenges for autoinjectors in Japan
10.3389/fmedt.2024.1461460 · ExternalCitation · doi-reference
Issues surrounding the development and review of medical devices
10.4091/iken.19.51 · ExternalCitation · doi-reference
Definition of the device lag and its measurement
10.4286/jjmi.79.273 · ExternalCitation · doi-reference
