Regulatory review time for approval of oncology drugs in Japan between 2001 and 2014. Considerations of changes, factors that affect review time, and difference with the United States

2015 ◽  
Vol 55 (5) ◽  
pp. 481-489 ◽  
Author(s):  
Hideki Maeda ◽  
Tatsuo Kurokawa
Keyword(s):  
United States ◽  
The United States ◽  
Regulatory Review ◽  
Review Time

Policy Punctuations and Regulatory Drug Review

2003 ◽  
Vol 15 (2) ◽  
pp. 157-191 ◽  
Author(s):  
Stephen J. Ceccoli
Keyword(s):  
United States ◽  
The United States ◽  
New Drugs ◽  
Regulatory Review ◽  
Review Time ◽  
University Center ◽  
The Past ◽  
Percent Increase ◽  
New Chemical Entities ◽  
Drug Review

The FDA has dramatically decreased the regulatory review time for new drugs since the early 1990s. For example, according to the Tufts University Center for the Study of Drug Development (CSDD), which conducts triennial analyses of new drug approvals in the United States, the average FDA review time for approved New Chemical Entities (NCEs) decreased from 35.6 months in 1984–86 to 16.8 months in 1996–98. Thus, in a little more than a decade, the FDA has essentially cut its average review time in half. In addition to the declining review times, the agency's workload, as measured in terms of the number of drugs approved each year, also rose considerably in the 1990s. Specifically, the agency approved a total of 232 NCEs between 1993 and 1999, compared to just 163 approvals during the previous seven-year span—a 42 percent increase. Figures 1 and 2 illustrate the agency's decreased review times and increased workload, respectively. Thus, over the past decade the FDA has approved more drugs and done so in less time than at any other period in history. Simply stated, this change in regulatory performance, especially the declining review times, has been absolutely stunning.

Rationales of delay and difference in regulatory review by Japan, the United States, and Europe among new drugs first approved in Japan

2021 ◽  
Author(s):  
Mototsugu Tanaka ◽  
Mayumi Idei ◽  
Hiroshi Sakaguchi ◽  
Ryosuke Kato ◽  
Daisuke Sato ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
New Drugs ◽  
Regulatory Review

scholarly journals The Ball is in Your Court: Agenda for Research to Advance the Science of Patient Preferences in the Regulatory Review of Medical Devices in the United States

2017 ◽  
Vol 10 (5) ◽  
pp. 531-536 ◽  
Author(s):  
Bennett Levitan ◽  
A. Brett Hauber ◽  
Marina G. Damiano ◽  
Ross Jaffe ◽  
Stephanie Christopher
Keyword(s):  
United States ◽  
Medical Devices ◽  
Patient Preferences ◽  
The United States ◽  
Regulatory Review

Is Chinese Tallowtree, Triadica sebifera, an Appropriate Target for Biological Control in the United States?

2014 ◽  
Vol 7 (2) ◽  
pp. 345-359 ◽  
Author(s):  
Gregory S. Wheeler ◽  
Jianqing Ding
Keyword(s):  
United States ◽  
Biological Control ◽  
Management Practices ◽  
Invasive Plant ◽  
Conflicts Of Interest ◽  
The United States ◽  
Great Promise ◽  
Invasive Weed ◽  
Triadica Sebifera ◽  
Regulatory Review

AbstractBiological control is one of the most common approaches used to manage invasive weeds of wetlands and other natural areas. Before candidate agents can be released, research is conducted to support biological control, which can be protracted and expensive, leading to a scientific and potentially lengthy regulatory review. To increase biological control safety, efficacy, and transparency, we suggest that during the early phases of a weed project, the feasibility of the invasive plant as a target should be studied explicitly. Our purpose here is to summarize information of an important invasive weed that can serve to judge whether the project is appropriate. Chinese tallowtree, Triadica sebifera, is one of the worst invasive species invading coastal wetlands and other riparian areas of the southeastern United States. Current management practices have not controlled the spread of this weed into these sensitive habitats. Initial surveys in the plant's native Chinese range for potential biological control agents have recovered several herbivore species that could be developed. These potential agents include defoliators, root and foliage feeders, and gall formers, whose biology, apparent host specificity, and impacts on plant fitness suggest that biological control offers great promise against Chinese tallowtree. When conducted during the initial phase of a project, this type of feasibility study can address potential conflicts of interest and risks, ultimately producing projects that are more effective and safer for biological control.

Human Abuse Liability Assessment of Tobacco and Nicotine Products: Approaches for Meeting Current Regulatory Recommendations

2021 ◽  
Author(s):  
Andrea Vansickel ◽  
Sarah Baxter ◽  
Neil Sherwood ◽  
Michael Kong ◽  
Leanne Campbell
Keyword(s):  
United States ◽  
The United States ◽  
Tobacco Product ◽  
Abuse Liability ◽  
Background Information ◽  
Regulatory Review ◽  
Tobacco Products ◽  
Public Health Officials ◽  
Regulatory Bodies ◽  
Study Designs

Abstract Many regulatory bodies now recommend that tobacco product manufacturers provide information regarding new tobacco products’ abuse liability to inform regulatory authorization of currently marketed tobacco products or new product applications (including premarket tobacco product applications in the United States). In addition, the US Food and Drug Administration (FDA) recommends including this information as part of modified risk tobacco product applications. Regulators, including FDA, and many public health officials and researchers consider abuse liability assessment a model which predicts the likelihood that the use of the tobacco product would result in addiction and be used repeatedly or even sporadically resulting in undesirable effects. Abuse liability of a new, potentially reduced harm product can also inform its ability to substitute completely for more harmful tobacco products. While many methods exist, no standard tobacco product abuse liability assessment has been established. The purpose of this review is to provide background information and practical recommendations for human abuse liability testing methods to meet tobacco regulatory needs. A combination of nicotine test product pharmacokinetic, subjective effect and/or behavioral response, and physiological response data relative to comparator products with known abuse liability satisfies some regulatory requirements. Implications: This review provides a practical inspection of the current, international regulatory recommendations for abuse liability assessment of tobacco and regulatory review of such information within the United States and also recommends study designs and methods for abuse liability testing of tobacco products based on scientific and regulatory knowledge. Given that tobacco product abuse liability testing is of increasing interest to regulatory bodies globally, especially with the emergence of novel tobacco products, this timely work provides background and functional recommendations for tobacco product abuse liability testing.

scholarly journals Assessing the Food and Drug Administration’s Risk-Based Framework for Software Precertification With Top Health Apps in the United States: Quality Improvement Study

10.2196/20482 ◽  
2020 ◽  
Vol 8 (10) ◽  
pp. e20482
Author(s):  
Noy Alon ◽  
Ariel Dora Stern ◽  
John Torous
Keyword(s):  
United States ◽  
Quality Improvement ◽  
Health Information ◽  
Digital Health ◽  
The United States ◽  
Health Condition ◽  
User Engagement ◽  
Regulatory Review ◽  
Regulatory Guidance ◽  
Health Apps

Background As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize the categorization of these apps to allow for efficient yet robust regulation is growing. However, regulators and researchers are faced with numerous challenges, as apps have a wide variety of features, constant updates, and fluid use cases for consumers. As past regulatory efforts have failed to match the rapid innovation of these apps, the US Food and Drug Administration (FDA) has proposed that the Software Precertification (Pre-Cert) Program and a new risk-based framework could be the solution. Objective This study aims to determine whether the risk-based framework proposed by the FDA’s Pre-Cert Program could standardize categorization of top health apps in the United States. Methods In this quality improvement study during summer 2019, the top 10 apps for 6 disease conditions (addiction, anxiety, depression, diabetes, high blood pressure, and schizophrenia) in Apple iTunes and Android Google Play Store in the United States were classified using the FDA’s risk-based framework. Data on the presence of well-defined app features, user engagement methods, popularity metrics, medical claims, and scientific backing were collected. Results The FDA’s risk-based framework classifies an app’s risk by the disease condition it targets and what information that app provides. Of the 120 apps tested, 95 apps were categorized as targeting a nonserious health condition, whereas only 7 were categorized as targeting a serious condition and 18 were categorized as targeting a critical condition. As the majority of apps targeted a nonserious condition, their risk categorization was largely determined by the information they provided. The apps that were assessed as not requiring FDA review were more likely to be associated with the integration of external devices than those assessed as requiring FDA review (15/58, 26% vs 5/62, 8%; P=.03) and health information collection (24/58, 41% vs 9/62, 15%; P=.008). Apps exempt from the review were less likely to offer health information (25/58, 43% vs 45/62, 72%; P<.001), to connect users with professional care (7/58, 12% vs 14/62, 23%; P=.04), and to include an intervention (8/58, 14% vs 35/62, 55%; P<.001). Conclusions The FDA’s risk-based framework has the potential to improve the efficiency of the regulatory review process for health apps. However, we were unable to identify a standard measure that differentiated apps requiring regulatory review from those that would not. Apps exempt from the review also carried concerns regarding privacy and data security. Before the framework is used to assess the need for a formal review of digital health tools, further research and regulatory guidance are needed to ensure that the Pre-Cert Program operates in the greatest interest of public health.

Does an Orphan Drug Policy Make a Difference in Access? A Comparison of Canada and Australia

2019 ◽  
Vol 50 (2) ◽  
pp. 166-172
Author(s):  
Joel Lexchin ◽  
Nicholas Moroz
Keyword(s):  
United States ◽  
Federal Government ◽  
Orphan Drug ◽  
Drug Policy ◽  
Review Process ◽  
Orphan Drugs ◽  
The United States ◽  
Regulatory Review ◽  
United States Food ◽  
States Food

Canada has been discussing whether to implement an orphan drug policy for more than 25 years. Recently, the federal government announced funding for orphan drugs starting in 2022, and the Canadian Senate has recommended that the country develop an orphan drug policy. This paper uses a list of orphan drugs approved by the United States Food and Drug Administration between 2008 and 2017, inclusive. It then compares Canada, which has no orphan drug policy, and Australia, which has had such a policy since 1997. There was no difference between the countries in the proportion of orphan drugs approved, the time drugs spent in the regulatory review process, and any delay in marketing the drugs in the respective countries compared to the United States. Both Canada and Australia approved virtually all of the drugs that offered a moderate to significant therapeutic improvement. If Canada hopes to provide faster access to orphan drugs, especially those that are therapeutically innovative, it will need to develop a policy that is significantly different from that in Australia.

Study on Promoting Use of Repair, Replacement and Mitigation Techniques in Maintenance Activities of Nuclear Power Plants

2018 ◽  
Author(s):  
Koji Dozaki ◽  
Takayuki Aoki ◽  
Koji Koyama ◽  
Masanori Kanno ◽  
Ryoichi Saeki
Keyword(s):  
United States ◽  
Nuclear Power ◽  
Power Plants ◽  
The United States ◽  
Inspection System ◽  
Regulatory Body ◽  
Regulatory Review ◽  
Technical Requirements ◽  
Corrective Measures ◽  
Maintenance Activities

Maintenance of nuclear power plant facilities involves activities comprising a large system composed of both plant hardware and human subsystems to assure safe and reliable operation. Maintenance activities are composed of inspection, evaluation and corrective measures. Corrective measures are countermeasures for aging degradation, e.g., resetting the inspection period based on the results of inspection and evaluation; mitigation of degradation phenomenon; repair or replacement; preventive maintenance; etc. The corrective measures merit special attention as they are important and valuable actions in order to promote continued efficient and safe plant operations. It is necessary to develop a set of regulatory and industrial technical requirements for a well-structured, documented set of standards, so that corrective measures can be used and applied uniformly and effectively. Currently the code and standard system is less developed in Japan than in the United States. In this study, the authors considered the relationship between degradation and maintenance and the difference of performance requirements between the plant construction stage and the in-service stage. This effort is intended to clarify the issues of regulation for maintenance activities, with an objective to help develop structured regulatory/industrial requirements with a code and standards consistent with appropriate corrective measures. The Nuclear Regulation Authority (NRA), the regulatory body in Japan, has reviewed the present Japanese inspection system in response to suggestions from the Integrated Regulatory Review Service (IRRS) mission established by International Atomic Energy Agency (IAEA). The NRA has also been developing a new regulatory inspection system similar to the Reactor Oversight Process (ROP) used in the United States. The expectation for the new Japanese inspection system is to focus regulations on plant issues with higher risk importance, considering both plant hardware and human subsystems. The new Japanese regulatory system addressing maintenance is also expected to enhance electric utilities ability to assure safety is self-motivated and sustained.

scholarly journals Assessing the Food and Drug Administration’s Risk-Based Framework for Software Precertification With Top Health Apps in the United States: Quality Improvement Study (Preprint)

2020 ◽  
Author(s):  
Noy Alon ◽  
Ariel Dora Stern ◽  
John Torous
Keyword(s):  
United States ◽  
Quality Improvement ◽  
Health Information ◽  
Digital Health ◽  
The United States ◽  
Health Condition ◽  
User Engagement ◽  
Regulatory Review ◽  
Regulatory Guidance ◽  
Health Apps

BACKGROUND As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize the categorization of these apps to allow for efficient yet robust regulation is growing. However, regulators and researchers are faced with numerous challenges, as apps have a wide variety of features, constant updates, and fluid use cases for consumers. As past regulatory efforts have failed to match the rapid innovation of these apps, the US Food and Drug Administration (FDA) has proposed that the Software Precertification (Pre-Cert) Program and a new risk-based framework could be the solution. OBJECTIVE This study aims to determine whether the risk-based framework proposed by the FDA’s Pre-Cert Program could standardize categorization of top health apps in the United States. METHODS In this quality improvement study during summer 2019, the top 10 apps for 6 disease conditions (addiction, anxiety, depression, diabetes, high blood pressure, and schizophrenia) in Apple iTunes and Android Google Play Store in the United States were classified using the FDA’s risk-based framework. Data on the presence of well-defined app features, user engagement methods, popularity metrics, medical claims, and scientific backing were collected. RESULTS The FDA’s risk-based framework classifies an app’s risk by the disease condition it targets and what information that app provides. Of the 120 apps tested, 95 apps were categorized as targeting a nonserious health condition, whereas only 7 were categorized as targeting a serious condition and 18 were categorized as targeting a critical condition. As the majority of apps targeted a nonserious condition, their risk categorization was largely determined by the information they provided. The apps that were assessed as not requiring FDA review were more likely to be associated with the integration of external devices than those assessed as requiring FDA review (15/58, 26% vs 5/62, 8%; <i>P</i>=.03) and health information collection (24/58, 41% vs 9/62, 15%; <i>P</i>=.008). Apps exempt from the review were less likely to offer health information (25/58, 43% vs 45/62, 72%; <i>P</i>&lt;.001), to connect users with professional care (7/58, 12% vs 14/62, 23%; <i>P</i>=.04), and to include an intervention (8/58, 14% vs 35/62, 55%; <i>P</i>&lt;.001). CONCLUSIONS The FDA’s risk-based framework has the potential to improve the efficiency of the regulatory review process for health apps. However, we were unable to identify a standard measure that differentiated apps requiring regulatory review from those that would not. Apps exempt from the review also carried concerns regarding privacy and data security. Before the framework is used to assess the need for a formal review of digital health tools, further research and regulatory guidance are needed to ensure that the Pre-Cert Program operates in the greatest interest of public health. CLINICALTRIAL

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