scholarly journals A comparison of the Food and Drug Administration’s and Health Canada’s regulatory decisions about failed confirmatory trials for oncology drugs: an observational study

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Joel Lexchin
Keyword(s):  
The United States ◽  
Clinical Implications ◽  
Additional Information ◽  
Surrogate Outcomes ◽  
The Us ◽  
Accelerated Approval ◽  
Regulatory Decisions ◽  
Health Canada ◽  
Confirmatory Trials ◽  
Confirmatory Trial

Abstract Background Oncology drugs are frequently approved on the basis of surrogate outcomes that require further trials to confirm the benefits, but at times these trials fail and regulators need to decide whether to withdraw approval for the indication and/or to remove the drug from the market. This study compares decisions by the Food and Drug Administration and Health Canada about oncology drugs that were approved using either Accelerated Approval (FDA) or Notice of Compliance with conditions (NOC/c, Health Canada) and that failed confirmatory trials. Methods Drug/indications approved by the FDA through its Accelerated Approval Pathway and that later failed confirmatory studies were identified from a published study and additional information on these drugs was collected from Drugs@FDA. Health Canada websites were searched on September 11, 2021 for the same group of drugs to determine if they were approved in Canada under the NOC/c pathway for the same indication as in the US. Information from both the FDA and Health Canada about these products was entered into an Excel spreadsheet. Decisions about whether to withdraw the drugs or remove the failed indication for the drug and requirements for confirmatory studies were compared. In addition, the dates of decisions by the two agencies were compared. Results Ten drug/indications were available for comparison. Regulatory decisions were similar in 4 cases, different in 1 case and could not be determined in the remaining 5, in 1 case because decisions were pending in both countries and in the other 4, because the NOC/c had not been fulfilled in Canada. The requirements for the confirmatory studies were similar in both countries. Decisions were made earlier in the United States. Conclusions This study shows that decisions made by Health Canada and the FDA about whether to withdraw a drug or remove a failed indication when drug/indications fail a confirmatory trial are usually similar, although the sample size on which this conclusion is made is small. The clinical implications of these similarities and differences should be explored.

scholarly journals Accelerated approval of non-cancer drugs by the US Food and Drug Administration: A protocol for a meta-epidemiological investigation

2020 ◽  
Author(s):  
Kenji Omae ◽  
Akira Onishi ◽  
Ethan Sahker ◽  
Toshi A Furukawa
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Cancer Drugs ◽  
Cancer Treatments ◽  
Trade Offs ◽  
The Us ◽  
The Status ◽  
Accelerated Approval ◽  
Confirmatory Trials ◽  
Confirmatory Trial

The US Food and Drug Administration (FDA)'s accelerated approval program, in which drugs are approved on the basis of surrogate endpoints, has been a source of controversy in the context of risk-benefit trade-offs. The FDA recently reported on the 25-year experience with the program and concluded that the low failure rate in post-approval confirmatory trials was evidence that the program was operating effectively. However, many studies have revealed manufacturers' poor adherence to obligation of conducting confirmatory trials, and also concerned the harm and cost of cancer drugs approved through this program based on the limited evidence. To date, few studies have investigated accelerated approval of non-cancer drugs. Therefore, the purpose of this study is to review trends in the FDA's utilization of its accelerated approval program for non-cancer drugs and clarify the status of fulfillment of social obligations by the FDA and sponsors in the program. The FDA' s documents will be reviewed at Drugs@FDA to identify pre-approval and confirmatory trials and regulatory updates for drug indications granted accelerated approval other than cancer treatments. We will further search PubMed, Google/Google Scholar, and the sponsors' websites to match each identified confirmatory trial to publications in the medical literature.

scholarly journals Probiotic Products in Canada with Clinical Evidence: What Can Gastroenterologists Recommend?

2008 ◽  
Vol 22 (2) ◽  
pp. 169-175 ◽  
Author(s):  
Gregor Reid ◽  
Kingsley Anukam ◽  
Tara Koyama
Keyword(s):  
United States Of America ◽  
Clinical Evidence ◽  
Health Benefit ◽  
The United States ◽  
World Health ◽  
Therapeutic Effects ◽  
The Us ◽  
Health Organization ◽  
Health Canada

Probiotics, defined as ‘live microorganisms, which when administered in adequate amounts, confer a health benefit on the host’, are finally becoming an option for gastroenterologists in Canada, after being available for many years in Japan, Europe and the United States of America. Unfortunately, Health Canada and the US Food and Drug Administration have not controlled the use of the term ‘probiotic’ or put into place United Nations and World Health Organization guidelines. The net result is that a host of products called ‘probiotics’ are available but are not truly probiotic. The aim of the present review was to discuss the rationale for probiotics in gastroenterology, and specifically examine which products are options for physicians in Canada, and which ones patients might be using. It is hoped that by clarifying what probiotics are, and the strengths and limitations of their use, specialists will be better placed to make recommendations on the role of these products in patient care. In due course, more clinically documented probiotics will emerge, some with therapeutic effects based on a better understanding of disease processes.

Levomilnacipran (Fetzima)

2013 ◽  
Vol 27 (4) ◽  
pp. 389-395 ◽  
Author(s):  
Megan M. Saraceni ◽  
Jineane V. Venci ◽  
Mona A. Gandhi
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Relevant Information ◽  
The United States ◽  
Major Depressive ◽  
Additional Information ◽  
The Us ◽  
Norepinephrine Reuptake Inhibitor ◽  
Scientific Meetings ◽  
Norepinephrine Reuptake

In July 2013, the US Food and Drug Administration approved levomilnacipran extended release (ER; Fetzima), a serotonin-norepinephrine reuptake inhibitor, for the treatment of adults with major depressive disorder. Levomilnacipran is an active enantiomer of the racemic drug milnacipran that is currently approved in the United States for the treatment of fibromyalgia. This article provides an overview of the mechanism of action, pharmacokinetic properties, clinical efficacy, safety, and tolerability of levomilnacipran ER. Relevant information was identified through a search of databases using the key word levomilnacipran. Additional information was obtained from fda.gov, by a review of the reference lists of identified articles, and from posters and abstracts from scientific meetings. Levomilnacipran ER, dosed once daily, is generally well tolerated and has demonstrated favorable effects compared to placebo in clinical trials of patients with major depressive disorder. The increased potency for norepinephrine reuptake inhibition is a characteristic that may represent a novel contribution for levomilnacipran. Additional studies comparing levomilnacipran ER to other commonly prescribed antidepressants are needed to further evaluate its place in therapy.

scholarly journals The effect of political affiliation on support for police drone monitoring in the United States

2019 ◽  
Vol 7 (2) ◽  
pp. 129-144
Author(s):  
Mattie N. Milner ◽  
Stephen Rice ◽  
Scott R. Winter ◽  
Emily C. Anania
Keyword(s):  
Social Identity Theory ◽  
Political Party ◽  
The United States ◽  
Political Affiliation ◽  
Unmanned Aerial Systems ◽  
Additional Information ◽  
Police Agencies ◽  
Political Protests ◽  
The Us ◽  
Aerial Systems

As unmanned aerial systems grow in popularity, police agencies are using this technology to provide aerial support for officers; however, public opinion could affect the success of this technological collaboration. Using social identity theory, researchers may be able to predict people’s support for various government projects. In a series of studies, participants were presented with a brief description of a proposal for using police drones to monitor political protests. Additional information was provided about the type of protest and type of person attending the protest. In general, conservatives were more supportive of police drones monitoring protests compared to liberals. However, this support was moderated by the type of participant and the type of protest; that is, support dropped when a participant believed that the protest supported their own political party beliefs. The current study provides a foundation for understanding what factors affect the public’s support of police incorporating drones into their daily workforce in the US.

Nanotechnology and Global Environmental Politics: Transatlantic Divergence

2016 ◽  
Vol 16 (3) ◽  
pp. 89-105 ◽  
Author(s):  
Kirsten Rodine-Hardy
Keyword(s):  
Industrial Revolution ◽  
Environmental Politics ◽  
The United States ◽  
Regulatory Regime ◽  
Global Environmental ◽  
The Us ◽  
Wait And See ◽  
Definition Of ◽  
Regulatory Decisions ◽  
The Eu

Nanotechnology has been celebrated as driving a new global industrial revolution that has the potential to harness economic growth and remediate the environment, yet could pose risks to health and the environment. Two of the largest economic actors, the EU and the US, have made very different regulatory decisions toward nanotechnology. The EU introduced an official definition of nanotechnology and created several new nano-specific regulations in recent years, whereas the United States has followed more of a “wait and see” policy. I argue that politics, not technology, best explains the divergence between the US and the EU in creating nano-specific regulations, and I introduce a regulatory regime framework to show why, how, and where politics affect divergent environmental politics. To support this argument, I employ comparative case analysis of the EU and US from 2000 to 2015.

scholarly journals Factors That Influence FDA Decisions for Postmarketing Requirements and Commitments During Review of Oncology Products

2018 ◽  
Vol 14 (1) ◽  
pp. e34-e41 ◽  
Author(s):  
Atsushi Hyogo ◽  
Masayuki Kaneko ◽  
Mamoru Narukawa
Keyword(s):  
United States ◽  
The United States ◽  
Clinical Safety ◽  
Pivotal Study ◽  
Number Of Patients ◽  
The Us ◽  
Safety Studies ◽  
Clinical Benefits ◽  
Accelerated Approval ◽  
Potential Factors

Purpose: With the recent use of expedited drug development and approval programs for several oncology products in the United States, the importance of postmarketing plans to confirm clinical benefits and safety is increasing. To discuss postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required for oncology products approved in the United States, we investigated the factors that influenced the US Food and Drug Administration (FDA) decisions for PMR/PMCs during FDA review. Methods: Characteristics of new drug approvals and PMR/PMCs for oncology products (new molecular entities and new therapeutic biologic products) in the United States between 2008 and 2015 were analyzed. Results: Of the 58 oncology products analyzed, PMR/PMCs were required for 54 products. The proportion of approvals that required confirmatory PMR/PMCs was 100% for accelerated approval (AA) and was 39% for regular approval (RA). Median development times for AA and RA were 7.41 and 7.50 years, respectively. Randomization, number of patients, and end point in pivotal studies were identified as key potential factors that influenced the decision to require PMR/PMCs for both confirmatory and clinical safety studies. Conclusion: Robustness of the pivotal study design was identified as one of the key factors for the decision by the FDA to require PMR/PMCs—in particular, significant PMR/PMCs, such as those for confirmatory studies. That is, the FDA approved products with surrogate markers and smaller studies but required PMR/PMCs to fully prove the risk-benefit profile in the postmarketing period.

Potential policy reforms to strengthen the accelerated approval pathway

2021 ◽  
Author(s):  
Anna Kaltenboeck ◽  
Amanda Mehlman ◽  
Steven D Pearson
Keyword(s):  
United States ◽  
Healthcare System ◽  
Life Science ◽  
The United States ◽  
New Drugs ◽  
Policy Reforms ◽  
Advantages And Disadvantages ◽  
The Us ◽  
Accelerated Approval ◽  
Us Fda

The accelerated approval pathway for new drugs in the United States is often praised but faces growing criticism of whether it is finding the appropriate balance between uncertainty, access and cost. To support efforts to strengthen the pathway, this paper provides an analysis of key concerns and the advantages and disadvantages of ten potential policy reforms – those achievable through the US FDA action alone, and those that would require a combination of government, payer and life science industry actions. Accelerated approval sits at the heart of many of the controversies regarding drug approvals and pricing, and this analysis provides perspectives on how best to strengthen the pathway within the broader landscape of an innovative US healthcare system.

scholarly journals United States updates recommendations for managing anthrax attacks

2002 ◽  
Vol 6 (19) ◽  
Author(s):  
R Harling
Keyword(s):  
United States ◽  
Working Group ◽  
Consensus Statement ◽  
The United States ◽  
Accidental Release ◽  
Additional Information ◽  
European Guidelines ◽  
Animal Trials ◽  
The Us

The United States (US) Working Group on Civilian Biodefence has recently published an updated consensus statement for the management of deliberate releases of anthrax (1). The recommendations are consistent with European guidelines, and offer some additional information. Evidence emerging from the deliberate releases of anthrax in the US postal system in October 2001 has been included, along with older data from the accidental release at Sverdlovsk in 1979, and from human and animal trials.

scholarly journals Effects of Date Labels and Freshness Indicators on Food Waste Patterns in the United States and the United Kingdom

2021 ◽  
Vol 13 (14) ◽  
pp. 7897
Author(s):  
Carter Weis ◽  
Anjali Narang ◽  
Bradley Rickard ◽  
Diogo M. Souza-Monteiro
Keyword(s):  
Food Waste ◽  
The United States ◽  
Policy Debate ◽  
Convenience Sample ◽  
Additional Information ◽  
The United Kingdom ◽  
The Us ◽  
Different Types ◽  
Packaged Foods ◽  
The Uk

To meet the target for Sustainable Development Goal 12.3, household food waste will need to be reduced by at least 284 million tonnes globally by 2030. American and British households waste a significant amount of food, and date labels are considered to be a contributor to this situation. Using a split-plot experimental design implemented on a survey administered to a convenience sample of UK and US consumers, we aimed to determine how different types of date labels and freshness indicators affect the stated likelihoods of discarding 15 foods. We find that not all date labels would lead to reductions in waste, and that semantics matter. Overall, the likelihood to waste across products was similar between the US and the UK; however, American consumers showed a larger response to the additional information provided by the freshness indicators. Our results shed new light on the ongoing policy debate related to national strategies for simplifying and harmonizing the use of date labels for packaged foods, as well as the potential effects from the use of freshness indicators.

Relation of Statistically Significant, Abnormal, and Typical WAIS-R VIQ-PIQ Discrepancies to Full Scale IQs

2000 ◽  
Vol 16 (2) ◽  
pp. 107-114 ◽  
Author(s):  
Louis M. Hsu ◽  
Judy Hayman ◽  
Judith Koch ◽  
Debbie Mandell
Keyword(s):  
Graphical Method ◽  
The United States ◽  
Full Scale ◽  
True Score ◽  
Absolute Value ◽  
Normative Population ◽  
The Us ◽  
The Mean ◽  
And Performance ◽  
Quadratic Models

Summary: In the United States' normative population for the WAIS-R, differences (Ds) between persons' verbal and performance IQs (VIQs and PIQs) tend to increase with an increase in full scale IQs (FSIQs). This suggests that norm-referenced interpretations of Ds should take FSIQs into account. Two new graphs are presented to facilitate this type of interpretation. One of these graphs estimates the mean of absolute values of D (called typical D) at each FSIQ level of the US normative population. The other graph estimates the absolute value of D that is exceeded only 5% of the time (called abnormal D) at each FSIQ level of this population. A graph for the identification of conventional “statistically significant Ds” (also called “reliable Ds”) is also presented. A reliable D is defined in the context of classical true score theory as an absolute D that is unlikely (p < .05) to be exceeded by a person whose true VIQ and PIQ are equal. As conventionally defined reliable Ds do not depend on the FSIQ. The graphs of typical and abnormal Ds are based on quadratic models of the relation of sizes of Ds to FSIQs. These models are generalizations of models described in Hsu (1996) . The new graphical method of identifying Abnormal Ds is compared to the conventional Payne-Jones method of identifying these Ds. Implications of the three juxtaposed graphs for the interpretation of VIQ-PIQ differences are discussed.

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