Why did the number of US FDA medical device guidelines begin to rise in the mid-2010s? A perspective
I Daizadeh - Expert Review of Medical Devices, 2022 - Taylor & Francis
ABSTRACT In the United States (US), the FDA regulates medical devices, a large and
diverse group of medical products. In 2020 alone, there were at least 5000 novel medical …
diverse group of medical products. In 2020 alone, there were at least 5000 novel medical …
Trademark and patent applications are structurally near-identical and cointegrated: Implications for studies in innovation
I Daizadeh - Iberoamerican Journal of Science Measurement and …, 2021 - eprints.rclis.org
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 …
between trademarks and patents, as it would suggest that similar exogenous pressures …
Factors that have an impact on abbreviated new drug application (ANDA) submissions
S Wittayanukorn, M Rosenberg, A Schick, M Hu… - … Innovation & Regulatory …, 2020 - Springer
Background Increasing generic drug price competition by facilitating abbreviated new drug
applications (ANDA) submission may help patients have access to affordable care. This …
applications (ANDA) submission may help patients have access to affordable care. This …
The impact of US medical product regulatory complexity on innovation: preliminary evidence of interdependence, early acceleration, and subsequent inversion
I Daizadeh - Pharmaceutical Research, 2023 - Springer
Purpose Is the complexity of medical product (medicines and medical devices) regulation
impacting innovation in the US? If so, how? Methods Here, this question is investigated as …
impacting innovation in the US? If so, how? Methods Here, this question is investigated as …
RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial …
I Daizadeh - Therapeutic Innovation & Regulatory Science, 2022 - Springer
Abstract The US Food and Drug Administration (FDA) regulates medical devices (MD),
which are predicated on a concoction of economic and policy forces (eg, supply/demand …
which are predicated on a concoction of economic and policy forces (eg, supply/demand …
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
I Daizadeh - Therapeutic innovation & regulatory science, 2021 - Springer
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 …
affected all daily activities. Has it also affected the number of United States (FDA) drug …
Since the mid-2010s FDA drug and biologic guidelines have been growing at a faster clip than prior years: is it time to analyze their effectiveness?
I Daizadeh - Therapeutic Innovation & Regulatory Science, 2021 - Springer
An Food and Drug Administration (FDA; Agency) guideline (which may include Guidance
Document, Compliance Policy Guide (CPG), Small Entity Compliance Guide, Information …
Document, Compliance Policy Guide (CPG), Small Entity Compliance Guide, Information …
US FDA Drug Approvals are persistent and polycyclic: insights into economic cycles, innovation dynamics, and National Policy
I Daizadeh - Therapeutic Innovation & Regulatory Science, 2021 - Springer
It is challenging to elucidate the effects of changes in external influences (such as economic
or policy) on the rate of US drug approvals. Here, a novel approach—termed the …
or policy) on the rate of US drug approvals. Here, a novel approach—termed the …
Trademark filings and patent application count time series are structurally near-identical and cointegrated: Implications for studies in innovation
I Daizadeh - arXiv preprint arXiv:2012.10400, 2020 - arxiv.org
Through time series analysis, this paper empirically explores, confirms and extends the
trademark/patent inter-relationship as proposed in the normative intellectual-property (IP) …
trademark/patent inter-relationship as proposed in the normative intellectual-property (IP) …
Historically Stagnate, the Number of US FDA Medical Device Guidelines Have Been Growing Quickly Since The Mid-2010s: While Partially Due to COVID-19 and …
I Daizadeh - 2021 - osf.io
In the United States (US), the Food and Drug Administration (FDA) regulates medical
devices (MDs). Though not a fair comparison but for illustrative purposes: a majority of …
devices (MDs). Though not a fair comparison but for illustrative purposes: a majority of …