The merging of medical products: Enhancing review of therapeutic and diagnostic combination products

By: Robert M. Califf, M.D. and Jill Hartzler Warner, J.D. Combination products – medical products that do not fit into the traditional categories of drugs, devices, or biological products – are a growing and important category of therapeutic and diagnostic products under FDA’s regulatory authority. Products in this category range from familiar products such as prefilled syringes and surgical kits to novel and innovative products, which target and enhance therapies. Examples of groundbreaking combination products include antibodies combined with drugs for targeted cancer therapy and products that mimic or replace organs, such as an artificial pancreas.These products, that combine drugs, devices, and/or biological product (“constituent parts”) with one another, come in three configurations. The constituent parts may be physically or chemically combined, co-packaged, or separately distributed with specific labeling for their combined use. Combination products pose unique challenges – both because they may involve new, complex technologies – and because their review at FDA often involves the expertise of more than one Center. While review of such products falls to a cross-center team of experts, it is led by the medical product Center responsible for the constituent part that provides the product’s primary mode of action, which, in the case of a syringe prefilled with a drug, for example, would be FDA’s Center for Drug Evaluat...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog FDA Source Type: news

Related Links:

Conclusion: Molecular mechanism and clinical efficacy of some of the emerging molecular targets for cancer chemotherapy have been briefly reviewed in the present article.
Source: Current Chemical Biology - Category: Biochemistry Source Type: research
Authors: Habban Akhter M, Sateesh Madhav N, Ahmad J Abstract The epidermal growth factor receptor (EGFR) is a cell surface receptor belonging to erythroblastic leukemia viral oncogene homologue (ErbB) family of tyrosine kinase. It plays critical role in the regulation of cell proliferation, survival and differentiation. The EGFR receptor is crucial in a variety of tumor development due to unlikely triggered by receptor overexpression, chromosomal mutation and or ligand-dependent receptor dimerization. The EGFR inhibition established a major therapeutic target in cancer therapy. The signal transduction pathway of EG...
Source: Artificial Cells, Nanomedicine and Biotechnology - Category: Biotechnology Tags: Artif Cells Nanomed Biotechnol Source Type: research
Publication date: Available online 10 July 2018Source: Journal of Pharmacological SciencesAuthor(s): Qin Chen, Haoran Zhang, Meng Wu, Qin Wang, Lusong Luo, Haikuo Ma, Xiaohu Zhang, Sudan HeAbstractAberrant activation of Hedgehog (Hh) signaling is associated with the development of numerous human cancers. Vismodegib is the first Hh inhibitor approved for anti-cancer therapy by targeting Smoothened (SMO), a critical regulator of the Hh pathway. However, acquisition of drug resistance to vismodegib occurs overtime. Apoptosis is a prevalent form of programmed cell death that is executed by caspases. Induction of tumor cell apo...
Source: Journal of Pharmacological Sciences - Category: Drugs & Pharmacology Source Type: research
Publication date: February 2018Source: Genomics, Proteomics &Bioinformatics, Volume 16, Issue 1Author(s): Changting Meng, Chunmei Bai, Thomas D. Brown, Leroy E. Hood, Qiang TianAbstractHuman gut microbiota play an essential role in both healthy and diseased states of humans. In the past decade, the interactions between microorganisms and tumors have attracted much attention in the efforts to understand various features of the complex microbial communities, as well as the possible mechanisms through which the microbiota are involved in cancer prevention, carcinogenesis, and anti-cancer therapy. A large number of studies...
Source: Genomics, Proteomics and Bioinformatics - Category: Bioinformatics Source Type: research
Abstract OBJECTIVES: To describe patient-reported symptoms and symptom clusters in patients with pancreatic cancer (PC) undergoing surgical resection. SAMPLE & SETTING: 143 patients with stage II PC undergoing surgical resection alone or with subsequent adjuvant chemoradiation or chemotherapy were recruited to participate in a nested, longitudinal, exploratory study through convenience sampling techniques from Thomas Jefferson University Hospital, a National Cancer Institute-designated cancer center. METHODS & VARIABLES: The Functional Assessment in Cancer Therapy-Hepatobiliary questionnaire was ...
Source: Oncology Nursing Forum - Category: Nursing Authors: Tags: Oncol Nurs Forum Source Type: research
In this study, we investigate mitochondrial energetics and mtDNA methylation in senescent cells, and evaluate the potential of humanin and MOTS-c as novel senolytics or SASP modulators that can alleviate symptoms of frailty and extend health span by targeting mitochondrial bioenergetics. Exercise versus the Hallmarks of Aging https://www.fightaging.org/archives/2018/06/exercise-versus-the-hallmarks-of-aging/ The paper I'll point out today walks through the ways in which exercise is known to beneficially affect the Hallmarks of Aging. The Hallmarks are a list of the significant causes of aging that I dis...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
Conclusion: This study suggests the potential therapeutic benefit of ETAS in enhancing anticancer effects by its combination with gemcitabine for patients with pancreatic cancer.
Source: In Vivo - Category: Research Authors: Tags: Experimental Studies Source Type: research
Cancer is a leading cause of death throughout the world, and cancer therapy remains a big medical challenge in terms of both its therapeutic efficacy and safety. Therefore, to find out a safe anticancer drug has been long goal for oncologist and medical scientists. Among clinically used medicines with no or little toxicity, fenofibrate is a drug of the fibrate class that plays an important role in lowering the levels of serum cholesterol and triglycerides while elevating the levels of high-density lipoproteins. Recently, several studies have implied that fenofibrate may exert anticancer effects via a variety of pathways in...
Source: Journal of Cancer - Category: Cancer & Oncology Authors: Tags: Review Source Type: research
Conclusion: The co-delivery of Gem and miR-21i using Au DENPs can be significantly promoted by UTMD technology, hence providing a promising strategy for effective pancreatic cancer treatments.
Source: Theranostics - Category: Molecular Biology Authors: Tags: Research Paper Source Type: research
Introduction: Hyperglycaemia is a significant cause of morbidity in cancer patients accounting for up to 5% of emergency oncology admissions (1). The incidence of hyperglycaemia in non-diabetic patients receiving anti-cancer therapy has been shown to be as high as 11.6% (2). One significant factor is the high doses of steroids administered either as part of the systemic anti-cancer treatment to control nausea and vomiting, or to palliate other cancer-related symptoms such as pain or anorexia. Patients with gastro-intestinal (GI) malignancies, in particular, often receive high doses of steroids as part of their chemotherapy...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research
More News: Blogging | Cancer | Cancer & Oncology | Cancer Therapy | Chemistry | Medical Devices | Pancreas | Pancreatic Cancer | Politics | Smokers | Study