Zobrazeno 1 - 10 of 40 pro vyhledávání: '"and Iraj Daizadeh"'
1
Singular secular Kuznets-like period realized amid industrial transformation in US FDA medical devices: a perspective on growth from 1976 to 2020
Autor: Iraj Daizadeh
Publikováno v: Expert Review of Medical Devices. 19:745-756
Introduction: Since inception, the United States (US) Food and Drug Administration (FDA) has kept a robust record of regulated medical devices (MDs). Based on these data, can we gain insight into the innovation dynamics of the industry, including the
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ab227a4e533d67d212ca50984a143b0a
https://doi.org/10.1080/17434440.2022.2139919
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2
Has the COVID-19 Crisis Affected the Growth of United States Food and Drug Administration Drug Approvals? The Answer Is not Yet! a Time Series (Forecasting) Study
Autor: Iraj Daizadeh
Publikováno v: Therapeutic Innovation & Regulatory Science
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-19; HCoV-19; COVID-19) has affected all daily activities. Has it also affected the number of United States (FDA) drug approvals over time? The short answer from empirical time series forecasti
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4a55f794669e208074edd2dbbbcff727
https://doi.org/10.2139/ssrn.4345254
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4
Trademark and patent applications are structurally near-identical and cointegrated: Implications for studies in innovation
Autor: Iraj Daizadeh
Publikováno v: Iberoamerican Journal of Science Measurement and Communication. 1:1-16
Objective. This paper seeks to test the existence of a “long-run” equilibrium (LRE) dynamic between trademarks and patents, as it would suggest that similar exogenous pressures concomitantly drive these metrics. The restraint in the divergence of
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::d92797e6ec8a212787f0aa9b5b22ae59
https://doi.org/10.47909/ijsmc.33
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5
The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion
Autor: Iraj Daizadeh
Is the complexity of medical product (medicines and medical devices) regulation impacting innovation in the US? If so, how? Here, this question is investigated as follows: Various novel proxy metrics of regulation (FDA-issued guidelines) and innovati
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bac941a26bb247f1a64f42f28519538b
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6
Why did the Number of US FDA Medical Device Guidelines Begin to Rise in the Mid-2010s? A Perspective
Autor: Iraj Daizadeh
Publikováno v: SSRN Electronic Journal.
An initial investigation of US medical device guidelines is presented, with the aid of those of medicines as qualitative comparator. Since the first recorded FDA medical device guideline (February 1975) until the mid-2010s, the number of medical devi
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::190647c23a134b6db6c4c2fe6d8356cc
https://doi.org/10.2139/ssrn.4217869
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8
Investigating Rates of Food and Drug Administration Approvals and Guidances in Drug Development: A Structural Breakpoint/Cointegration Timeseries Analysis
Autor: Iraj Daizadeh
Publikováno v: Therapeutic Innovation & Regulatory Science. 54:1056-1067
The number of original and supplemental ANDAs, BLAs, NDAs, and Biosimilars FDA drug/biologic approvals (Approvals) has risen dramatically in the recent years, incidentally, so has the number of issued FDA guidances (Guidances). It is hypothesized tha
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d11c6d0d0a7b765154614285e8ae2b02
https://doi.org/10.1007/s43441-020-00123-5
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9
Pulmonary Arterial Hypertension: A Case Study in FDA Expedited Program Designations
Autor: Iraj Daizadeh
Publikováno v: Therapeutic Innovation & Regulatory Science. 53:264-269
FDA expedited program designations (EPDs) are intended to facilitate drug development for serious conditions with an unmet medical need. There are over 10 FDA-approved therapies for the rare disease pulmonary arterial hypertension (PAH). This work in
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::21438fb7e9acbc89dda2e351c023de78
https://doi.org/10.1177/2168479018778529
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10
Since 1976, the Dynamics of US FDA Medical Device Premarket Notifications are Trending Downwards and Premarket Approvals are Trending Upwards, Yet Together There is a Clear Single 20-Year Period: Does this Represent a Structural Transformation for the Industry?
Autor: Iraj Daizadeh
There has been concern that the severe acute respiratory syndrome coronavirus 2 (COVID-19) crises may have stifled medical device (MD) development. However, what if a decline was expected based on some non-COVID-19 force? Since 1976, it is shown that
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::ac734a84b8ff2b863ca27c5e0bc374bb
https://doi.org/10.31219/osf.io/896vw
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