Comparison of the Safety and Efficacy of Two Topical Antiseptic Products: Chlorhexidine Gluconate + Isopropyl Alcohol and Povidone- Iodine + Isopropyl Alcohol

2007 ◽  
Vol 12 (3) ◽  
pp. 156-163 ◽  
Author(s):  
Greg Art

Abstract While antiseptic products containing a combination of chlorhexidine gluconate and isopropyl alcohol (CHG+IPA) have gained in popularity over the past several years in preparing and maintaining vascular access sites, the data used to support their use over products containing povidone-iodine (PVP-I) have been based solely on comparisons of aqueous CHG or CHG+IPA to aqueous PVP-I alone. No studies have compared aqueous CHG or CHG+IPA to PVP-I+IPA or aqueous PVP-I preceded by IPA. When compared using methods established by the U.S. Food and Drug Administration (FDA) and the American Society of Testing and Materials (ASTM), the safety and efficacy of PVP-I+IPA was found to be less irritating and faster acting than CHG+IPA; both PVP-I+IPA and CHG+IPA demonstrated persistence for 7 days.

2018 ◽  
Vol 56 (4) ◽  
Author(s):  
Elitza S. Theel ◽  
D. Jane Hata

ABSTRACT Since the emergence and dissemination of Zika virus (ZIKV) in late 2015, our understanding of the biology, transmission, clinical disease, and potential sequelae associated with infection has markedly expanded. Over the past 2 years, the number of diagnostic assays for ZIKV has increased from none in 2015 to 5 serological assays and 14 molecular assays in 2017, all with emergency use authorization granted through the U.S. Food and Drug Administration. Here we provide an update on ZIKV, addressing what we have collectively learned since the outbreak began, including a summary of currently available diagnostic assays for this virus.


2008 ◽  
Vol 71 (6) ◽  
pp. 1277-1286 ◽  
Author(s):  
KARL C. KLONTZ ◽  
PATRICK V. McCARTHY ◽  
ATIN R. DATTA ◽  
JUDY O. LEE ◽  
DAVID W. K. ACHESON ◽  
...  

From 1986 to 2006, the incidence of listeriosis in the United States dropped from approximately seven to three cases per million population, a reduction that most likely reflects the joint efforts of industry, government, consumers, and academia. Herein, we describe the U.S. Food and Drug Administration (FDA) strategy over the past three decades to combat listeriosis. Specifically, we discuss early actions taken to address outbreaks during the 1980s, policy decisions regarding the presence of Listeria monocytogenes in FDA-regulated foods, FDA compliance programs with L. monocytogenes components, enforcement actions to remove L. monocytogenes–contaminated products from the market (i.e., recalls) or to prevent entry of such products into the market (i.e., import detentions and refusals), research milestones, outreach and education efforts, and selected special projects. Evolving demographic trends in the United States may pose a challenge to further reduction of the incidence of listeriosis.


1974 ◽  
Vol 4 (1) ◽  
pp. 95-107 ◽  
Author(s):  
Henry E. Simmons

The 1962 Amendments to the Food, Drug, and Cosmetic Act have substantially increased the accountability of manufacturers of new drugs, both by raising standards for clinical testing as well as requiring, for the first time, a demonstration of proof of efficacy. Critics of the new regulatory system of the Food and Drug Administration (FDA) which imposes the requirements, have called for the repeal of the new standards on the grounds that they are stringent to the point of being counterproductive, reflect an unwarranted and excessive concern over drug safety, and have jeopardized the position of the U.S. in the worldwide development of new drugs. The author defends the regulatory system against these criticisms by demonstrating the importance of the scientific standards it has deemed essential for evaluating and approving new drug applications. Evidence of tragedy caused by inefficacious and unsafe drugs used in other countries but not in the U.S. supports FDA concern over safety and efficacy, and indicates that through its caution, the U.S. has doubtlessly been spared similar tragedy. Finally, worldwide trends in new drug development are investigated and it is shown that many factors are involved in the variation in the number and variety of drugs introduced in the marketplace of any given country which have nothing to do with its regulatory policies. It is concluded that FDA's regulatory system serves to assure the safety and efficacy of all drugs introduced into this country, while at the same time, continues to support and encourage the development of significant new drugs.


Author(s):  
Joshua M. Sharfstein

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.


2021 ◽  
pp. 107815522110379
Author(s):  
Katie Xu ◽  
Elizabeth Hansen

Review objective There have been several advances in the field of myelodysplastic syndromes over the past year, yielding two new US Food and Drug Administration drug approvals. The pharmacology, pharmacokinetics, clinical trials, therapeutic use, adverse effects, clinical use controversies, product description, and upcoming trials for myelodysplastic syndromes novel agents luspatercept-aamt and decitabine/cedazuridine are reviewed. Data sources This review article utilized primary information obtained from both the published studies involved in the approval of luspatercept-aamt and decitabine/cedazuridine and package inserts for the respective medications. This review article utilized secondary information obtained from National Comprehensive Cancer Network guidelines using filters and keywords to sustain information relevancy as well as key studies using the keywords, “luspatercept-aamt, myelodysplastic syndromes, decitabine, cedazuridine, hypomethylating agent, ASTX727” from scholarly journal database PubMed. Data summary Myelodysplastic syndromes consist of myeloid clonal hemopathies with a diverse range of presentation. Until recently, there have been relatively few new therapies in the myelodysplastic syndromes treatment landscape. On April 3, 2020 the US Food and Drug Administration approved Reblozyl®(luspatercept-aamt), then on July 7, 2020, the US Food and Drug Administration approved INQOVI® (decitabine and cedazuridine). Luspatercept-aamt acts as a erythroid maturation agent through differentiation of late-stage erythroid precursors. The safety and efficacy of luspatercept-aamt was demonstrated in the MEDALIST trial, a phase III trial in patients with very low-intermediate risk refractory myelodysplastic syndromes and ring sideroblasts. Luspatercept-aamt met both primary and secondary endpoints of transfusion independence of 8 weeks or longer and transfusion independence of 12 weeks or longer, respectively. Decitabine/cedazuridine has a unique mechanism of action in which decitabine acts as a nucleoside metabolic inhibitor promoting DNA hypomethylation and cedazuridine then prevents degradation of decitabine. The safety and efficacy of decitabine/cedazuridine was shown in the ASCERTAIN study, a phase III trial in patients with intermediate or high risk myelodysplastic syndromes or chronic myelomonocytic leukemia. The primary outcome evaluated was 5-day cumulative area under the curve between decitabine/cedazuridine and IV decitabine as well as additional outcomes including safety. Decitabine/cedazuridine met primary outcome and had a similar safety profile to IV decitabine. Conclusion The novel myelodysplastic syndromes agents luspatercept-aamt and decitabine/cedazuridine provide a clinical benefit in the studied populations.


2021 ◽  
pp. 174077452110505
Author(s):  
Dionne Price ◽  
John Scott

Background The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration have been leaders in advancing science to protect and promote public health by ensuring that safe and effective drugs and biological products are available to those who need them. Recently, new therapeutic discoveries, increased understanding of disease mechanisms, the need for innovation to optimally use resources, and global public health crises have led to an evolving drug development landscape. As a result, the U.S. Food and Drug Administration and medical product developers are faced with unique challenges and opportunities. The U.S. Food and Drug Administration is proactively meeting the challenges of this evolving landscape through various efforts, including the Complex Innovative Trial Design Pilot Meeting Program. Our focus, here, will be on the pilot meeting program. Methods The U.S. Food and Drug Administration has defined a process to facilitate the implementation of the Complex Innovative Trial Design Pilot Meeting Program. The process is transparent and outlines the steps and timeline for submission, review, and meetings. Results Five submitted meeting requests have been selected for participation in the Complex Innovative Trial Design Pilot Meeting Program. Conclusion The pilot meeting program has been successful in further educating stakeholders on the potential uses of complex innovative designs in trials intended to provide substantial evidence of effectiveness. The selected submissions, thus far, have all utilized a Bayesian framework. The reasons for the use of Bayesian approaches may be due to the flexibility provided, the ability to incorporate multiple sources of evidence, and a desire to better understand the U.S. Food and Drug Administration perspective on such approaches. We are confident the pilot meeting program will have continued success and impact the collective goal of bringing safe and effective medical products to patients.


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