Role Of Drug Administration Research Articles

The U.S. Food and Drug Administration's role in improving radiation dose management for medical X-ray imaging devices.

The U.S. Food and Drug Administration (FDA) has been concerned with minimizing the unnecessary radiation exposure of people for half a century. Manufacturers of medical X-ray imaging devices are important partners in this effort. Medical X-ray imaging devices are regulated by FDA under both its electronic product regulations andits medical device regulations. FDA also publishes guidance documents that represent FDA's current thinking on a topic and provide a suggested or recommended approach to meet the requirements of a regulation or statute. FDA encourages manufacturers to develop medical devices that conform to voluntary consensus standards. Use of these standards is a central element of FDA's system to ensure that all medical devices marketed in the U.S. meet safety and effectiveness requirements. FDA staff participate actively in the development and maintenance of these standards, often advancing or introducing new safety and dose management requirements. Use of voluntary consensus standards reduces the amount of time necessary to evaluate a premarket submission and reduces the burden on manufacturers. FDA interacts with industry and other stakeholders through meetings with industry groups, public meetings, public communications, and through the development of voluntary consensus standards. In these interactions, FDA staff introduce new concepts for improving the safety of these devices and provide support for similar initiatives from professional organizations. FDA works with all stakeholders to achieve its mission of protecting and promoting the public health.

Heterogeneity in treatment effects across diverse populations.

Differences in patient characteristics, including age, sex, and race influence the safety and effectiveness of drugs, biologic products, and medical devices. Here we provide a summary of the topics discussed during the opening panel at the 2018 Johns Hopkins Center for Excellence in Regulatory Science and Innovation symposium on Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities. The goal of this session was to provide a brief overview of FDA-regulated therapeutics, including drugs, biologics and medical devices, and some of the major sources of heterogeneity of treatment effects (HTE) related to patient demographics, such as age, sex and race. The panel discussed the US Food and Drug Administration's role in reviewing and regulating drugs, devices, and biologic products and the challenges associated with ensuring that diverse patient populations benefit from these therapeutics. Ultimately, ensuring diverse demographic inclusion in clinical trials, and designing basic and clinical research studies to account for the intended patient population's age, sex, race, and genetic factors among other characteristics, will lead to better, safer therapies for diverse patient populations.

"Who's Really Regulating? Who's Benefiting?" Exploring Black Stakeholders' Awareness and Trust in the Food and Drug Administration's Role as a Tobacco Regulator

Blacks/African Americans have experienced direct public health harm from US governmental agencies (eg, police violence, Tuskegee syphilis experiment) that may influence perceptions of the trustworthiness of government messages regarding tobacco products. Consequently, we sought to explore Black Americans' awareness of and trust in the FDA's role as a tobacco regulator. Data were from 2 focus groups conducted with a purposive sample of 23 Black stakeholders in Los Angeles, California. Discussions were audio-recorded and transcribed verbatim for analysis. Although most (N = 14; 61%) participants were aware of the FDA's role as a tobacco regulator, they all noted that the Black community in Los Angeles is not aware. Recurrent across the focus groups were discussions about distrust in the FDA with 4 main contributing factors: (1) that the FDA is influenced by the tobacco, agricultural, and pharmaceutical industries; (2) that the FDA is influenced by money and politics; (3) that the FDA is a bureaucracy exercising monopoly and power; and (4) that the FDA lacks technical capacity and competence to regulate tobacco products. Study findings highlight opportunities for the FDA to increase awareness and build trust in their tobacco regulatory role through communication campaigns targeted at Black Americans, and community engagement with Black stakeholders.

Antipsychotic-induced metabolic effects in the female rat: Direct comparison between long-acting injections of risperidone and olanzapine.

Several antipsychotics have well-known adverse metabolic effects. Studies uncovering molecular mechanisms of such drugs in patients are challenging due to high dropout rates, previous use of antipsychotics and restricted availability of biological samples. Rat experiments, where previously unexposed animals are treated with antipsychotics, allow for direct comparison of different drugs, but have been hampered by the short half-life of antipsychotics in rodents. The use of long-acting formulations of antipsychotics could significantly increase the value of rodent models in the molecular characterization of therapeutic and adverse effects of these agents. However, as long-acting formulations have rarely been used in rodents, there is a need to characterize the basic metabolic phenotype of different antipsychotics. Using long-acting olanzapine injections as a positive control, the metabolic effects of intramuscular long-acting risperidone in female rats were investigated for the first time. Like olanzapine, risperidone induced rapid, significant hyperphagia and weight gain, with concomitant increase in several plasma lipid species. Both drugs also induced weight-independent upregulation of several genes encoding enzymes involved in lipogenesis, but this activation was not confirmed at the protein level. Our findings shed light on the role of drug administration, drug dose and nutritional status in the development of rodent models for adverse metabolic effects of antipsychotic agents.

The Food and Drug Administration's role in promoting consistent labels for generic drugs.

The product information for a prescription drug— commonly called its label—is the full description of the drug’s indications for use, method of administration, warnings, contraindications, and potential adverse events. It is written by the manufacturer of the brandname drug, approved by the US Food and Drug Administration (FDA), and published when the drug initially is marketed. As new effectiveness or safety information becomes available during the period of marketing exclusivity, the manufacturer must update the label and maintain it as an accurate reference. Once a brand-name drug loses its market exclusivity, the manufacturers of generic versions must disseminate a label that mimics the safety information for the brand-name drug. The labels of generic drugs are important to public health; over 84% of all prescriptions that are filled in the United States are for generic drugs. 1 Frequently, serious new safety is

The Food and Drug Administration's Role in Establishing and Maintaining Safeguards for Contact Lenses and Contact Lens Care Products

The Food and Drug Administration's Role in Establishing and Maintaining Safeguards for Contact Lenses and Contact Lens Care Products

Pharmacotherapy and pregnancy: highlights from the Third International Conference for Individualized Pharmacotherapy in Pregnancy.

To address provider struggles to provide evidence-based, rational drug therapy to pregnant women, this third Conference was convened to highlight the current progress and research in the field. Speakers from academic centers, industry, and governmental institutions spoke about: the Food and Drug Administration's role in pregnancy pharmacology and the new labeling initiative; drug registries in pregnancy; the pharmacist's role in medication use in pregnancy; therapeutic areas such as preterm labor, gestational diabetes, nausea and vomiting in pregnancy, and hypertension; breast-feeding and medications; ethical challenges for consent in pregnancy drug studies; the potential for cord blood banks; and concerns about the fetus when studying drugs in pregnancy. The Conference highlighted several areas of collaboration within the current Obstetrics Pharmacology Research Units Network and hoped to educate providers, researchers, and agencies with the common goal to improve the ability to safely and effectively use individualized pharmacotherapy in pregnancy.

Clopidogrel, Warfarin, and Statins: Pharmacogenetics versus Laboratory Monitoring - What You Need to Know

This article discusses the use of routine genetic and platelet function testing in the setting of clopidogrel treatment, the use of pharmacogenetics to determine warfarin dosing, predictive genetic testing for statin efficacy and toxicity, cost-effectiveness, and the United States Federal Drug Administration's role in pharmacogenetic data.

Complementary and alternative medical therapies

Complementary and alternative medical therapies include herbs, acupuncture, and mind-body therapies. This review highlights the findings of recently published studies of complementary and alternative medical therapies and epilepsy, and provides an update of the US Food and Drug Administration's role in regulating herbal products. Complementary and alternative medical therapies are often tried by patients with epilepsy, frequently without physician knowledge. Many modalities have been evaluated in patients with epilepsy, though methodological issues preclude any firm conclusions of efficacy or safety. Some herbal medicines have been shown experimentally to have mechanisms of action relevant to epilepsy and promising actions in animal models. There is currently a paucity of credible evidence to support the use of complementary and alternative medical therapies in patients with epilepsy. Herbal medicines traditionally used for epilepsy and compounds isolated from them, as well as other herbal medicines and their constituent compounds that have been shown experimentally to have mechanisms of action relevant to epilepsy, should undergo further preclinical evaluation with a view towards clinical development under the new US Food and Drug Administration guidelines. Additional studies of other, nonherbal complementary and alternative medical therapies are also warranted based on anecdotal observations or pilot studies that suggest a favorable risk-benefit ratio.

Nurse's role in evaluating early treatment of acute pain during triage in ER

The purpose of this study is to define the nurse's role in the evaluation and early treatment of acute pain during triage. The assumption is that the treatment of acute pain in A&E by the triage nurse, in certain well selected cases, improves the level of care provided. The study's subject population is represented by all the users accessing A&E between 13th June 2005 and 13th July 2005, and presenting acute pain. The isolated sample is represented by users whose pain can be attributed to the following clinical conditions: musculoskeletal pain, contusions and sprains, fractures, headaches, earache, toothache and renal or biliary colic. The investigation was performed with the use of a grid by the triage nurse and the VAS (Visual Analogue Scale) to measure the intensity of the pain, whereas a dedicated protocol was followed for drug administration. In the period considered, the overall number of users (population) reporting to A& E was 2443. Of these 439 users (sample) (19%) complained of acute pain attributable to the above clinical conditions. The role of the triage nurse in pain management is undoubtedly important in the phase of evaluation using dedicated scales. The nurse's role in drug administration remains to be defined, given that this research demonstrated how even in the presence of medium-high or high VAS levels, the acceptance of pharmacological treatment at triage is somewhat limited. This aspect will provide an interesting basis for future research aimed at understanding to what extent cultural or individual elements are responsible for this attitude.

Examples on the role of drug administration on toxicity in mice and rats

Examples on the role of drug administration on toxicity in mice and rats

Arriving at a “New View” of Women's Sexual Problems

This essay offers an all-embracing narrative of the “new view” project to explain how and why a feminist critique of current sex problem nomenclature, an alternative vision, and an activist campaign have emerged since 1999. The story begins with 15 years of urology-promoted medicalization of men's sexuality and the building of a female market near the end of the 1990s. The Food and Drug Administration role is illuminated by the author's advisory panel experience and the FDA's proposed guidelines for testing sex drugs for women. The prevailing theory of women's sexual problems is traced to Masters and Johnson's biased research and continuing debates about orgasm. Finally, the origins of the “new view” campaign are described: a growing discomfort with the aggressive roles of urology and the drug industry in women's sexual medicine, the decision to take public as well as professional positions, the creation of a working group, and ongoing activism.

Dual Material Rapid Prototyping Techniques for the Development of Biomedical Devices. Part 1: Space Creation

Polymeric drug delivery devices play an important role in drug administration. However, the current polymeric drug delivery device fabrication methods lack precision. This impairs the quality of the devices, resulting in a decrease in the efficiency and effectiveness of drug delivery. The concept of building parts layer by layer out of powdered raw materials makes selective laser sintering (SLS) a suitable process for fabricating polymeric matrix drug delivery devices. The current SLS process is not capable of processing two or more materials separately. This work explores the possibilities of SLS performing a dual material operation by developing two process models. These two processes can then be integrated to form a dual or expanded multimaterial fabrication technique and act as a foundation for future work in multimaterial applications such as polymeric drug delivery device fabrication. Accordingly, two papers are presented. In this paper, Part 1, the focus is on the first process, which is a space creation technique in which a space is created by varying the density of a first representative material using heat during sintering. Three methods - one based on a vacuum and a place method, and the other two based on two variations of a laser compacting method - were tested. Results have shown that by varying the laser power during sintering, it is possible to create channels in which a second material can be deposited.

A novel approach to the characterization of polar liquids: Part 1: pure liquids

Liquid dosage forms, generally based on aqueous solutions, take an important role in drug administration. The approaches to a theoretical description of solvent and solubility properties have not yet proved completely satisfying. In this work, the Debye equation, which describes well polar and nonpolar molecules in an ideal gas, is extended to liquids. For this purpose, the Debye equation was modified and the term ( E i/ E) was introduced ( E i=internal electric field, E=applied external electric field). Pure polar and nonpolar solvents were measured between 290.7 and 343.2 K. The values of ( E i/ E) were compared with the correlation factor g of the Kirkwood–Fröhlich equation, a measure for molecular pair correlations. For polar solvents, the relationship E i/ E= m(1/ T)+ b as a function of temperature T was found. Associating compounds showed negative values of ( E i/ E) with a strong temperature dependency; the latter can be expressed by the slope m. A correlation between ∣ m∣ and the corresponding Hildebrand solubility parameter δ could be established. This new approach allows to describe polar hydrogen-bonding liquids and provides a tool for a more rational design of liquid dosage forms.

Blood safety. The Food and Drug Administration's role.

The federal government has a role in protecting consumers from threats to the blood supply. These threats range from the residual risks of known infection, to emerging infections that may contaminate the blood supply, to complacency in the area of adherence to product standards and Current Good Manufacturing Practices. The Food and Drug Administration is tasked with oversight of the safety of the nation's blood supply. The Food and Drug Administration's regulation of blood and blood components includes preapproval for products entering interstate commerce and adherence to Current Good Manufacturing Practices for all blood components. Oversight for Current Good Manufacturing Practices compliance includes inspection and reporting requirements. These regulatory programs are coupled with the Public Health Service's ongoing research and epidemiological surveillance. The goals of these programs are to prevent another infectious disease epidemic from infecting the blood supply as did the acquired immunodeficiency syndrome in the early 1980s and to further improve blood safety.

28th Annual Meeting of the Society for Obstetric Anesthesia and Perinatology

28th Annual Meeting of the Society for Obstetric Anesthesia and Perinatology

Toxicology then and now

A review of the history of the evolution of the science of toxicology from the original concepts of Paracelsus through the early development of analytical chemistry and its contributions to the detection of toxic substances in foods and drugs as these have led to modern regulatory rules for public protection is presented. The legal actions taken to protect against adulteration of food prior to the early steps by the U.S. Department of Agriculture that concluded with the passage of the 1906 Food and Drug Act are systematically documented. The history is reviewed of the Food and Drug Administration's role in the use of animal toxicity studies to develop reasonable criteria for safety of foods and drugs for man. Modern concepts of molecular distribution, metabolism, and excretion of substances in the animal body are discussed as these impinge on the so-called “protection index.” The legal and often litigious controversies over the claimed carcinogenicity of chemical substances is documented with comments on the Delaney dilemma and the role of in vitro tests in toxicology. The review concludes with discussion of the hazards of use of stochastic mathematical models to assess carcinogenicity and suggests that the criteria employed in the report of the Scientific Committee of the Food Safety Council are properly structured to give a contemporary evaluation of all the currently available data. References give documentation of events over the past 200 years that explain the present state of toxicology as a discipline.

DNA Probes

The emergence of recombinant DNA technology in the 1970s has given rise to new diagnostic techniques based on DNA probes. The Food and Drug Administration's interest in these probes stems from its regulatory responsibilities regarding DNA probes as medical devices. The agency also sees DNA probes as valuable tools in meeting its mission of identifying, preventing, and resolving public health problems, especially in the area of food safety. The development of DNA probes for genetic diseases is raising medical and ethical questions that must be addressed by the medical community, whose ultimate responsibility must be to see that this new technology is used wisely, appropriately, and correctly.The author writes about DNA probes, a spin-off technology from recombinant DNA research, from two perspectives: that of a physician, and that of the federal Commissioner of Food and Drugs. Young discusses the Food and Drug Administration's role in regulating DNA probes, as well as the agency's interest in using the probes to confront public health problems such as food pathogens. He also comments on some aspects of molecular biology's growing role in medicine. Young emphasizes that the FDA's responsibility for regulating DNA probes is limited, and that the medical community is obligated to ensure that the probes are used appropriately as diagnostic aids, particularly when screening for genetic disease.

The Food and Drug Administration's Role in the Protection of Human Subjects

The Food and Drug Administration's Role in the Protection of Human Subjects

The Food and Drug Administration's Role in the Use of Plastic Materials

The Food and Drug Administration's Role in the Use of Plastic Materials