Navigating the mammography quality standard act in USA: Role of US FDA and future scopes of regulation.

BACKGROUND: The Mammography Quality Standards Act (MQSA) has significant impact on providing high-quality mammography services for the early detection of breast cancer. MQSA emphasizes quality assurance, regulatory compliance, and patient safety. It guides technological integration, ensuring uniform quality across the United States of America (USA). This review synthesizes key MQSA information, analysing compliance, and facilitating policy discussions for improvements, aiming to inspire further policy research in cancer screening by adopting MQSA's success factors. METHODS: The review spanned 1997 to 2023, adhering to Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Databases like PubMed, ScienceDirect, and Google Scholar were searched for relevant literature. Selection criteria covered English-language journals, US Food and Drug Administration (FDA) guidelines, and professional organizational standards, revealing key aspects of MQSA and breast cancer diagnostics in the USA. RESULTS AND DISCUSSION: MQSA's legislative aspects guarantee the effectiveness of regulations for high-quality mammography. It addresses technology, emphasizes inspections, and balances compliance with healthcare burdens. Procedural guidelines prioritize patient outcomes, minimize errors, and address access disparities. Regular updates are crucial to align screening services with technological changes, maintaining safety and accuracy nationwide. CONCLUSION: The FDA's collaboration with stakeholders, including medical specialists and patient advocacy groups, has contributed to crucial legislative aspects of MQSA. The accuracy of mammography screenings has significantly improved by MQSA's installation of stringent quality and regulatory standards. Compliance with MQSA guidelines led to higher accuracy, safety, and better detection rates. Ongoing efforts must aim to refine guidelines, address emerging challenges, and optimize breast cancer detection.

Fecal microbiota transplantation: History, procedure and regulatory considerations.

Fecal microbiota transplantation (FMT) is a medical treatment which involves the transfer of feces from a healthy donor to a recipient to restore the balance of gut microbiota and improve clinical outcomes. FMT has gained recognition in recent years due to its effectiveness in treating recurrent Clostridioides difficile infections (rCDI) and other gastrointestinal disorders. Additionally, it has been studied as an intervention for some other conditions, like inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). This review covers regulatory considerations related to FMT, including the current state of FMT regulation and the need for further research to fully understand the safety and efficacy of this treatment. For transplantation of fecal microbiota, the Food and Drug Administration (FDA) classifies the treatment as an investigational new drug (IND), which typically requires physicians and scientists to submit an IND application. Ethical issues surrounding FMT, including the necessity of informed consent from donors and recipients and the potential transmission of infectious agents, are also discussed. Overall, FMT has the potential to offer significant therapeutic benefits, but it also raises regulatory and ethical considerations that require careful consideration. Further research is necessary to fully comprehend risks and benefits of FMT and to develop guidelines for its use in clinical practice.

Comparison of Antimicrobial Efficacy of Cinnamon Bark Oil Incorporated and Probiotic Blend Incorporated Mucoadhesive Patch against Salivary Streptococcus mutans in Caries Active 7-10-year-old Children: An In Vivo Study.

INTRODUCTION: Among the various plants studied, cinnamon has emerged as a potential herbal antimicrobial agent. Besides the medicinal plants, recently probiotics have also been recognized to affect cinnamon bark oil Streptococcus mutans (S. mutans) and other harmful oral and gut microflora. AIM AND OBJECTIVE: This placebo-controlled study aims to compare the antimicrobial potential of cinnamon bark oil incorporated and probiotic blend [Lactobacillus plantarum (TSP-Lp1), and Lactobacillus rhamnosus (TSP-Lrh1)] incorporated mucoadhesive patch against salivary S. mutans in caries active 7-10-year-old children. DESIGN: It was a double-blinded placebo-controlled study with n = 60. They were randomly allotted into three groups-Group I: Cinnamon patch, group II: probiotic patch, and group III: control patch (placebo) with n = 20 in each group. MATERIALS AND METHODS: The study was carried out in three phases. In the first phase, the minimal inhibitory concentration (MIC) of cinnamon bark oil was determined against S. mutans followed by the formulation of cinnamon and probiotic patches. After a washout period of 2 weeks and a collection of baseline saliva samples, these patches were tested on the subjects from respective groups for 14 days with twice a day placement protocol. On the 15th day, saliva samples were collected and cultured, CFU/mL of the saliva of S. mutans for each subject was recorded and compared with baseline samples. Feedback in the form of a questionnaire was obtained from the patients. STATISTICAL ANALYSIS: Descriptive statistics, paired t-test for intragroup comparison, unpaired t-test for intergroup comparison, analysis of variance (ANOVA) for intergroup comparison, and post hoc Scheffe's. RESULTS: The results showed that both cinnamon patch and probiotic patch were comparable to each other in terms of their anti-S. mutans activity. The intragroup comparison of the CFU/mL count showed a highly significant reduction from baseline to post-intervention for both the groups (p = 0.001). CONCLUSION: Both cinnamon and probiotic blend have a strong antimicrobial property owing to their ability to cause significant reduction in salivary S. mutans and both the patches showed good patient acceptance. HOW TO CITE THIS ARTICLE: Gandhi HA, Srilatha KT, Deshmukh S, et al. Comparison of Antimicrobial Efficacy of Cinnamon Bark Oil Incorporated and Probiotic Blend Incorporated Mucoadhesive Patch against Salivary Streptococcus mutans in Caries Active 7-10-year-old Children: An In Vivo Study. Int J Clin Pediatr Dent 2020;13(5):543-550.

Evaluation of moxifloxacin-hydroxyapatite composite graft in the regeneration of intrabony defects: A clinical, radiographic, and microbiological study.

BACKGROUND: The formation of new connective periodontal attachment is contingent upon the elimination or marked reduction of pathogens at the treated periodontal site. An anti-microbial agent, i.e. moxifloxacin has been incorporated into the bone graft to control infection and facilitate healing during and after periodontal therapy. MATERIALS AND METHODS: By purposive sampling, 15 patients with at least two contralateral vertical defect sites were selected. The selected sites in each individual were divided randomly into test and control sites according to split-mouth design. Test site received moxifloxacin-hydroxyapatite composite graft and control site received hydroxyapatite-placebo gel composite graft. Probing depth (PD) and Clinical attachment level (CAL) were assessed at baseline, 3, 6, 9, and 12 months. Bone probing depth (BPD) and hard tissue parameters such as amount of defect fill, percentage of defect fill, and changes in alveolar crest were assessed at baseline, 6, and 12 months. Changes in subgingival microflora were also assessed by culturing the subgingival plaque samples at baseline and at 3-month follow-up. The clinical, radiographic, and microbiological data obtained were subjected to statistical analysis using descriptive statistics, paired sample t-test, independent t-test, and contingency test. RESULTS: On intragroup comparison at test and control sites, there was a significant improvement in all clinical and radiographic parameters. However, on intergroup comparison of the same, there was no statistically significant difference between test and control sites at any interval. Although test sites showed slightly higher amount of bone fill, it was not statistically significant. There was a significant reduction in the counts of Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis at both sites from baseline to 3 months. In addition, there was a significant reduction at test sites as compared to control sites at 3-month follow-up (P = 0.003 and P = 0.013). CONCLUSION: The reduction in microbial counts found in test sites at 3-month follow-up could not bring similar significant improvements in the clinical and radiographic parameters though the test sites showed slightly higher bone fill.

Methotrexate: a gold standard for treatment of rheumatoid arthritis.

Rheumatoid arthritis (RA) is a painful, debilitating disease characterized by inflammation of the joints, with the proliferation of the synovium and the progressive erosion of cartilage and bone. The treatment of RA is still unsatisfactory, but a number of powerful disease-modifying antirheumatic drugs have become available, such as methotrexate (MTX). Even in the current era of biological targeted therapies, MTX remains the initial preferred antirheumatic drug and is considered to be the gold standard for treatment of RA. The combination of its perceived efficacy, acceptable safety profile, and low cost, as well as decades of clinical experience, makes MTX the cornerstone of treatment for RA and the anchor drug in combination with various biological agents. In this review, the authors aim to summarize the research done in the field of drug delivery systems of MTX according to its routes of administration for treatment of RA. The last part of the review addresses combination therapy with MTX and future direction in the drug delivery of MTX. This review also provides the reader with a general overview of RA and its therapeutic strategies with respect of MTX, which may bring uniformity in medical practice for effective management of RA.

Development, in vitro and in vivo evaluation of novel injectable smart gels of azithromycin for chronic periodontitis.

Periodontitis is an inflammatory condition affecting teeth resulting in progressive destruction of periodontal ligaments, resorption of alveolar bone and loss of teeth. Treatment of periodontitis includes surgical and non surgical management. Systemic antibiotics are also used for the treatment of periodontitis. The aim of this research was to formulate smart gel system of azithromycin (AZT) and to evaluate in vitro and in vivo for non-surgical treatment of chronic periodontitis. Azithromycin dihydrate, used systemically in the treatment of periodontitis, was formulated into smart gels using biodegradable, thermosensitive polymer Pluronic® F-127 (PF-127) and Hydroxy Ethyl Cellulose (HEC) as copolymer. The prepared smart gels were evaluated for sterility, content uniformity, gelation temperature and time, syringeability, rheological behavior, in vitro diffusion and in vivo efficacy in human patients. The prepared smart gels were clear and transparent, sterile, thermoresponsive and injectable. Viscosity of gels increased with increase in concentration of polymer/co-polymer and also with temperature. They gelled in short response time below the body temperature. In vitro release studies showed controlled drug release which was influenced significantly by the properties and concentration of PF-127 and HEC. In vivo efficacy studies showed a significant improvement (p <0.001) in clinical parameters such as gingival index, probing pocket depth, clinical attachment level, bleeding index and plaque index. The developed azithromycin smart gel system is a novel approach for the treatment of chronic periodontitis since it reduces the dose and side effects, bypasses the usual surgical procedures and improves patient compliance.

Regulations of Medical Devices in Regulated Countries: A Comparative Review.

The term "medical device" covers a vast range of equipment, from simple tongue depressors to hemodialysis machines. Like medicines and other health technologies, they are essential for patient care. With the increased use of medical devices, stringent regulatory standards are required to ensure that the devices are well studied, safe, and well tolerated. Recently, introduced guidelines and amendments in the laws of the US, Europe, and Canada provide adequate guidance for both manufacturers and competent authorities to prevent defects and performance failures efficiently and appropriately. A defective device may result in inaccurate patient results, leading to misdiagnosis, delays in treatment, adverse events, injuries, or even death. Therefore, a thorough review of the medical device before being released for use by the public and effective monitoring of the medical device once placed on the market are crucial.