Food And Drug Administration Regulations Research Articles

A Descriptive Longitudinal Study of Changes in Vape Shop Characteristics and Store Policies in Anticipation of the 2016 FDA Regulations of Tobacco Products, Including E-Cigarettes.

After proposing the “Deeming Rule” in 2014, the U.S. Food and Drug Administration (FDA) began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette) products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles–area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations) at two time points one year apart to better understand what vape shop retailers would do given FDA’s soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014) and Year 2 surveying 61 shops (2015–2016). Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2) were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule). Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc.) over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations.

Impact of Federal Regulatory Changes on Clinical Pharmacology and Drug Development: the Common Rule and the 21st Century Cures Act.

The Federal Policy for the Protection of Human Subjects, generally referred to as the "Common Rule," is the basis for the human research protection policies of 16 signatory federal agencies and governs virtually all federally funded research involving humans. The Common Rule was originally published in 1991. It has been recognized that changes to the Common Rule are needed to accommodate changes in the research environment and advances in information technology. The Department of Health & Human Services (HHS) issued an Advance Notice of Proposed Rulemaking in the Federal Register in 2011 and a Notice of Proposed Rulemaking in 2015. The final rule was published on January 19, 2017, just prior to the change in presidential administrations. The long gestation of the new Common Rule reflects the difficulty of obtaining consensus on a number of controversial issues. HHS received more than 2100 public comments on the proposed rule. The revised rule introduces important changes that may be particularly relevant to clinical pharmacology research and drug development. These include: (1) revised informed consent requirements, (2) procedures for "broad consent" to facilitate secondary research use of identifiable private information and/or biological specimens, (3) a mandate to promote review by a single institutional review board (IRB) for oversight of federally funded domestic cooperative research involving multiple institutions, (4) expansion of the categories of exempt research, and (5) removal of the requirement for annual continuing IRB review of research in which the remaining activities are limited to data analysis or accessing clinical follow-up data. Also noteworthy are proposed revisions not included in the final rule, including one to extend the Common Rule to multicenter studies that are not federally funded and one to require informed consent for research use of de-identified biological specimens. Major changes could also be coming for approval of new drugs by the Food and Drug Administration (FDA), although it is not a signatory to the Common Rule. The 21st Century Cures Act, which became law in December 2016, enables faster drug approvals by expanding the kinds of evidence, beyond traditional clinical trials, that the FDA can consider when reviewing new drug applications. For example, the law allows greater use of surrogate markers and data from "real-world experience" to evaluate a drug's efficacy. The Cures Act requires HHS and the FDA to harmonize differences between the Common Rule and FDA regulations for protection of human subjects in research.

Consortium on Methods Evaluating Tobacco: Research Tools to Inform US Food and Drug Administration Regulation of Snus.

The US Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this article is to describe these assessment methods using a US manufactured "snus" as the test product. In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This article integrates COMET's findings over the last 4 years. Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm.

Written Instructions vs. Audiology Service for PSAP Use

Written Instructions vs. Audiology Service for PSAP Use

Public Knowledge and Credibility Perceptions of the FDA as a Tobacco Regulator.

Since the U.S. Food and Drug Administration (FDA) was granted regulatory authority over tobacco products in 2009, few studies have examined perceived credibility of the FDA in this role. The current study assessed knowledge and credibility of the FDA as a regulator of tobacco products. In a nationally representative survey of U.S. adults (N = 4758), we assessed knowledge that the FDA regulates the manufacture, distribution, and marketing of cigarettes, and credibility of the FDA as a tobacco regulator. We examined demographic differences in knowledge and credibility, and associations of knowledge and trust in government with credibility perceptions. Less than half of respondents reported knowing the FDA regulates how cigarettes are sold (46.8%) and advertised (49.7%), and only 36.0% knew the FDA regulates how cigarettes are made, with few demographic differences. Respondents reported that the FDA was moderately credible in regulating tobacco. Knowledge of the FDA as a tobacco regulator and trust in government were the strongest predictors of credibility. Being of younger age, being White (compared to African American), and being male were associated with higher credibility ratings of the FDA. Much of the public still does not know that the FDA regulates tobacco products, and credibility perceptions are moderate. Greater knowledge of the FDA's regulatory role was associated with higher credibility; efforts that increase the public's understanding of the FDA's role as a tobacco regulator may positively impact views of the agency's credibility. This may in turn improve public reception to the FDA's messages and regulations. This study is the first to show nationally representative estimates of both knowledge and credibility of the FDA as a tobacco regulator. Our research shows further that knowledge of the FDA's tobacco regulatory roles is likely to be an important factor related to perceived credibility of the FDA. Increasing the public's knowledge of the FDA's roles may enhance the agency's credibility, which can improve public reception to messages and regulations.

Family Building by Same-Sex Male Couples via Gestational Surrogacy.

AbstractBest estimates suggest that the number of households with same-sex male couples is increasing. One option for family building by same-sex male couples is gestational surrogacy. Embryos would be generated in vitro, using the biologic father's sperm with donor oocytes, and another woman (the gestational carrier) would undergo an embryo transfer to bear a child. Conceiving via gestational surrogacy requires advance planning, not only to coordinate the oocyte donor and gestational carrier but also to comply with regulations set forth by the Food and Drug Administration (FDA). The American Society for Reproductive Medicine (ASRM) has also published recommendations for practices using gestational carriers, which, in many cases, are more stringent than the FDA regulations. This article will review the FDA regulations and ASRM recommendations and their implications for same-sex male couples who plan to conceive via gestational surrogacy.

Competing Policy Windows in Biotechnology: The FDA, the 21st Century Cures Act, and Laboratory‐Developed Tests

AbstractIn 2014, the U.S. Food and Drug Administration (FDA) proposed taking a more active role in the regulation of laboratory‐developed tests (LDTs). Meanwhile, the U.S. House of Representatives embarked upon the 21st Century Cures initiative to develop legislation to expedite the development of new biotechnology innovations. During that initiative and in the public comments responding to the draft guidance, there was significant disagreement as to whether the increased FDA regulation of LDTs was beneficial or detrimental to biotechnology. Both the FDA guidance document and the 21st Century Cures Act came about due to the opening of a window of opportunity created by the convergence of circumstances. The question is whether the windows of opportunity are competing and how to resolve this competition. This study will investigate these questions through a qualitative case study. It will also provide recommendations for resolving policy disputes involving wicked problems like biotechnology policy.

Drug Master File Filing in US, Europe, Canada and Australia

Purpose : A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation, it is submitted solely at the discretion of the DMF holder. The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product. The present work gives the Detailed idea on how to file Drug Master File in US, EUROPE, CANADA, AUSTRALIA. Approach : A Drug Master File is a submission of information to the FDA to permit the FDA to review this information in support of a third party's submission without revealing the information to the third party. In US, DMF filing was done through NDA for drugs, ANDA for generics and BLA for Biologics. In Europe, DMF filing was done through MAA via centralized procedure for eligible products and for other products via decentralized procedure was used. In CANADA, DMF filing was done through NDS for both drugs and biologic products, where as in AUSTRALIA different application processes and regulatory requirements apply depending on the type of therapeutic goods that is applied. Findings : This gives you clear vision on how to file Drug master file in US, EUROPE, CANADA and AUSTRALIA. This paper also gives you the comparison of DMF fling procedure in the above-mentioned countries so that reader can have clear idea on how to file DMF and different concerns on DMF among the above counties. Conclusion : The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, Packaging and the cGMP status of any Drug product for humans. The content and the format for Drug Master File is used to obtain marketing Authorization. The main objective of the DMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a marketing authorization grant. Now from 2016 onwards most of the regulated countries will use eCTD or their electronic format for their DMF submission.

International Electrotechnical Commission (IEC) and Food and Drug Administration (FDA) efforts to develop standards for ultrasound physiotherapy

Ultrasound physiotherapy devices produce acoustic energy, typically in the low MHz range, to generate deep heat for relief of pain and spasms, and have been used since the 1940’s. The IEC and the FDA have an interrelated history of developing standards for these devices. The IEC produced the first such standard “Testing and calibration of ultrasound therapeutic equipment”(1963). The FDA, with the IEC document as guide, developed its own “Ultrasonic Therapy and Surgery Products Performance Standard”(1978, 2012). Then the IEC, with FDA involvement and using many of the FDA’s concepts, produced “Medical electrical equipment—Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment (1984, 2000, 2009) and “Ultrasonics—Physiotherapy systems—Field Specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz” (1996, 2007, 2013). FDA personnel are also currently leading an IEC effort to write a standard dealing with new, lower frequency physiotherapy. The FDA is also committed to harmonizing FDA regulations with IEC standards whenever possible. This presentation recounts the history of these efforts and examines some similarities and differences among the documents.

Vitamin Fortification of Fluid Milk.

Vitamin concentrates with vitamins A and D are used for fortification of fluid milk. Although many of the degradation components of vitamins A and D have an important role in flavor/fragrance applications, they may also be source(s) of off-flavor(s) in vitamin fortified milk due to their heat, oxygen, and the light sensitivity. It is very important for the dairy industry to understand how vitamin concentrates can impact flavor and flavor stability of fluid milk. Currently, little research on vitamin degradation products can be found with respect to flavor contributions. In this review, the history, regulations, processing, and storage stability of vitamins in fluid milk are addressed along with some hypotheses for the role of vitamin A and D fortification on flavor and stability of fluid milk.

Preapproval Access and Right-to-Try Initiatives: What Are We Willing to Give Up?

There is a growing concern within the US Food and Drug Administration (FDA) and the pharmaceutical/biotechnology communities about state-based initiatives to provide access to drugs that are in the early stages of development. These legislative bills allow a patient to circumvent the protections afforded by regulated procedures as embodied in FDA regulation and guidance. Over the course of more than 80 years, the latter have served to best ensure the safety and therapeutic efficacy of new medicines and have evolved into an effective set of protections of human privacy, dignity, and fairness. To undermine these longstanding principles may have consequences which we, as society, must be prepared to address. This article examines the dynamic tensions that exist between the perceived best interests of the individual patient, the patient community, legislators, regulators, physicians, and the society at large. Decisions have consequences and, too often, these fail to be considered in the process of choosing the pathway that, in a context fraught with uncertainty, best meets a desperate need.

Twenty-First Century In Vitro Toxicology Testing Methods and the Assessment of e-Cigarettes

Twenty-First Century <i>In Vitro</i> Toxicology Testing Methods and the Assessment of e-Cigarettes

The Trend of Voluntary Warnings in Electronic Nicotine Delivery System Magazine Advertisements.

Some manufacturers of electronic nicotine delivery systems (ENDS) voluntarily carried health warnings in their advertisements. This study examined these voluntary warnings in magazine ads and plotted their trends between 2012 and early 2015. ENDS magazine ads were obtained through Kantar media and warnings were collected from the Chicago Public Library or the Trinkets and Trash surveillance system. The prevalence of voluntary warnings, warnings with the specific capitalized word “WARNING”, and MarkTen warnings were examined after being weighted using factors related to exposure between January 2012 and March 2015. Five brands (MarkTen, NJOY, MISTIC, and some Blu) carried warnings during the study period. The prevalence of warnings post 2012 that contained a description of nicotine did not significantly increase until the launch of MarkTen, which also happened several months before April 2014 when the U.S. food and drug administration (FDA) published its proposed deeming rule. In addition, none of these warnings met the criteria required by the FDA in the final rules. Voluntary warnings, particularly MarkTen warnings, significantly increased in ENDS magazine ads between 2014 and 2015. It is important to monitor how ENDS manufacturers will comply with the FDA regulation related to warnings and how this regulation will ultimately impact ENDS risk perceptions and use.

Engineering Therapeutic T Cells: From Synthetic Biology to Clinical Trials.

Engineered T cells are currently in clinical trials to treat patients with cancer, solid organ transplants, and autoimmune diseases. However, the field is still in its infancy. The design, and manufacturing, of T cell therapies is not standardized and is performed mostly in academic settings by competing groups. Reliable methods to define dose and pharmacokinetics of T cell therapies need to be developed. As of mid-2016, there are no US Food and Drug Administration (FDA)-approved T cell therapeutics on the market, and FDA regulations are only slowly adapting to the new technologies. Further development of engineered T cell therapies requires advances in immunology, synthetic biology, manufacturing processes, and government regulation. In this review, we outline some of these challenges and discuss the contributions that pathologists can make to this emerging field.

FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans

The United States Food and Drug Administration (FDA) ensures that patients in the U.S. have access to safe and effective medical devices. The Division of Neurological and Physical Medicine Devices reviews medical technologies that interface with the nervous system. This article addresses how to navigate the FDA's regulatory landscape to successfully bring medical devices to patients.

FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine

The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, “This salt does not supply iodide, a necessary nutrient.” If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine.

Test anxiety

Test anxiety

Abuse liability assessment of an e-cigarette refill liquid using intracranial self-stimulation and self-administration models in rats

BackgroundThe popularity of electronic cigarettes (ECs) has increased dramatically despite their unknown health consequences. Because the abuse liability of ECs is one of the leading concerns of the Food and Drug Administration (FDA), models to assess it are urgently needed to inform FDA regulatory decisions regarding these products. The purpose of this study was to assess the relative abuse liability of an EC liquid compared to nicotine alone in rats. Because this EC liquid contains non-nicotine constituents that may enhance its abuse liability, we hypothesized that it would have greater abuse liability than nicotine alone. MethodsNicotine alone and nicotine dose-equivalent concentrations of EC liquid were compared in terms of their acute effects on intracranial self-stimulation (ICSS) thresholds, acquisition of self-administration, reinforcing efficacy (i.e., elasticity of demand), blockade of these behavioral effects by mecamylamine, nicotine pharmacokinetics and nicotinic acetylcholine receptor binding and activation. ResultsThere were no significant differences between formulations on any measure, except that EC liquid produced less of an elevation in ICSS thresholds at high nicotine doses. ConclusionsCollectively, these findings suggest that the relative abuse liability of this EC liquid is similar to that of nicotine alone in terms of its reinforcing and reinforcement-enhancing effects, but that it may have less aversive/anhedonic effects at high doses. The present methods may be useful for assessing the abuse liability of other ECs to inform potential FDA regulation of those products.

Transvaginal mesh: a historical review and update of the current state of affairs in the United States.

Transvaginal mesh usage has been at the forefront of popular media and academic debate for the past 10years. Several US Food and Drug Administration (FDA) communications, society statements, and research articles have been written in an attempt to define and articulate the classification system, safety data, and efficacy of this approach to transvaginal surgery. In this review, we explore the history of transvaginal mesh surgery for pelvic organ prolapse (POP), review FDA and society statements, and research current practice in the United States. We searched the English language literature using PubMed for articles related to safety and monitoring of transvaginal mesh and reviewed all FDA publication and notices and gynecology and urogynecology society statements on its use in the United States. We then reviewed 22 articles and grouped them into several sections. Mesh used to augment transvaginal repair of POP was introduced in the United States in 2005 without clinical safety and efficacy data. In the subsequent years of use, both major and minor complications were increasingly reported, leading to several FDA notifications and warnings. The type of mesh used, reporting and classifications systems, and provider usage has varied widely over time. We present a historical review of transvaginal mesh use for pelvic organ prolapse in the United States from 2005 to 2016. There continues to be heated debate among practitioners about balancing the efficacy of mesh use to decrease recurrent prolapse and complications. Research into safety and efficacy, along with tighter FDA regulations, is ongoing.

Tobacco Product Use Among Adults - United States, 2013-2014.

While significant declines in cigarette smoking have occurred among U.S. adults during the past 5 decades, the use of emerging tobacco products* has increased in recent years (1-3). To estimate tobacco use among U.S. adults aged ≥18 years, CDC and the Food and Drug Administration (FDA) analyzed data from the 2013-2014 National Adult Tobacco Survey (NATS). During 2013-2014, 21.3% of U.S. adults used a tobacco product every day or some days, and 25.5% of U.S. adults used a tobacco product every day, some days, or rarely. Despite progress in reducing cigarette smoking, during 2013-2014, cigarettes remained the most commonly used tobacco product among adults. Young adults aged 18-24 years reported the highest prevalence of use of emerging tobacco products, including water pipes/hookahs and electronic cigarettes (e-cigarettes). Furthermore, racial/ethnic and sociodemographic differences in the use of any tobacco product were observed, with higher use reported among males; non-Hispanic whites, non-Hispanic blacks, and non-Hispanics of other races(†); persons aged <45 years; persons living in the Midwest or South; persons with a General Educational Development (GED) certificate; persons who were single/never married/not living with a partner or divorced/separated/widowed; persons with annual household income <$20,000; and persons who were lesbian, gay, or bisexual (LGB). Population-level interventions that focus on all forms of tobacco product use, including tobacco price increases, high-impact anti-tobacco mass media campaigns, comprehensive smoke-free laws, and enhanced access to help quitting tobacco use, in conjunction with FDA regulation of tobacco products, are critical to reducing tobacco-related diseases and deaths in the United States.(§).