Combination products: modernizing the regulatory paradigm

Hunter, Nina L.; Sherman, Rachel E.

doi:10.1038/nrd.2017.66

Cited by 19 publications

(15 citation statements)

References 1 publication

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“…There is increasing recognition of the need for timely development of combination therapies and the corresponding need for combination-specific regulation. In particular, the 21st Century Cures Act supports efficient combination therapy development by promoting clear communication regarding market expectations, coordination between research centers, and compliance with good manufacturing processes [83].…”

Section: Regulatory Guidancementioning

confidence: 99%

“…The FDA promotes combination drug development only for “serious diseases,” defined as “a disease or condition associated with morbidity that has substantial impact on day-to-day functioning” [82] and has issued specific guidance on combination drug development for cancer, tuberculosis, and HIV infection [84-86]. From a regulatory standpoint, the demonstrated success and continued potential benefit of combination treatment in all of these disorders have paved the way for efficient development of effective combination therapy for AD [83].…”

Section: Regulatory Guidancementioning

confidence: 99%

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Treatment Combinations for Alzheimer’s Disease: Current and Future Pharmacotherapy Options

Cummings

Tong

Ballard

2019

JAD

422

275

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Although Alzheimer’s disease (AD) is the world’s leading cause of dementia and the population of patients with AD continues to grow, no new therapies have been approved in more than a decade. Many clinical trials of single-agent therapies have failed to affect disease progression or symptoms compared with placebo. The complex pathophysiology of AD may necessitate combination treatments rather than monotherapy. The goal of this narrative literature review is to describe types of combination therapy, review the current clinical evidence for combination therapy regimens (both symptomatic and disease-modifying) in the treatment of AD, describe innovative clinical trial study designs that may be effective in testing combination therapy, and discuss the regulatory and drug development landscape for combination therapy. Successful combination therapies in other complex disorders, such as human immunodeficiency virus, may provide useful examples of a potential path forward for AD treatment.

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Section: Regulatory Guidancementioning

confidence: 99%

Section: Regulatory Guidancementioning

confidence: 99%

Treatment Combinations for Alzheimer’s Disease: Current and Future Pharmacotherapy Options

Cummings

Tong

Ballard

2019

JAD

422

275

View full text Add to dashboard Cite

show abstract

“…The U.S. Food and Drug Administration (FDA) has regulated combination products since 1970 [ 28 ]. For addressing regulatory issues with these products, the U.S. Food, Drug, and Cosmetic Act was revised in 1990 [ 29 ]. These products were defined as “ constitut(ing) a combination of a drug, device, or biological product ” [ 29 , 30 ].…”

Section: Origin Definition and Designationmentioning

confidence: 99%

“…For addressing regulatory issues with these products, the U.S. Food, Drug, and Cosmetic Act was revised in 1990 [ 29 ]. These products were defined as “ constitut(ing) a combination of a drug, device, or biological product ” [ 29 , 30 ]. With the development of manufacturing technology, the universe and complexity of combination products are becoming increasingly prevalent.…”

Section: Origin Definition and Designationmentioning

confidence: 99%

Regulatory perspectives of combination products

Tian

Wang

et al. 2022

Bioactive Materials

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Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological product. The product research and development, clinical translation as well as regulatory evaluation of combination products are complex and challenging. This review firstly introduced the origin, definition and designation of combination products. Key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented. Preclinical and clinical evaluation of combination products was discussed. Lastly, the research prospect of regulatory science for combination products was described. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality and performance of combination products. Taken together, the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

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“…20,21 Moreover, the use of biochemical elements, that is, growth factors and cells in bone-tissue-engineering techniques, is hypothetically very useful; however, in reality, bio-material structures incorporating biochemical elements are limited due to their basic regulatory needs high cost. 22 Analysis initiatives, scientific translation and marketing campaigns benefit significantly from materialonly methods that remove biological elements. Instead, they are trying to use the body's own cells to regenerate bones.…”

mentioning

confidence: 99%

Materials science and design principles of therapeutic materials in orthopedic and bone tissue engineering

Liang

Dong

Shen

et al. 2021

Polymers for Advanced Techs

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The successful materials design for bone-tissue engineering needs to understand the structure and composition of host bone tissue, and selecting appropriate biomimetic natural or tunable synthetic materials (biomaterials), such as polymers, bioceramics, metals, and composites. Materials that improve bone tissue engineering have tremendous potential for clinical applications to treat and regenerate various bone injuries and fractures. The drive to design bone grafts for bridging the gaps in orthopedic tissue regeneration results in a significant research thrust for designing and developing material for bone tissue regeneration. Recently, numerous challenges, including biomaterial designing, can well suit the biological, chemical and mechanical microenvironment of natural orthopedic tissues and adopt vascularization. Novel bio-inspired materials attempt to enhance the biofunctionality that reconstruct microlevel biofactor and topographical signals from the extracellular environment are rapidly developing. The most important paradigm shift in orthopedic tissue engineering is the careful selection of scaffold, signals, and cell types to design biomaterials. Notwithstanding, the clinical outcome of orthopedic tissue regeneration was so vibrant years ago; however, so far, it failed to achieve the expected results and failed to translate in the clinical setting. In the current review, we discuss the aims and mechanism of bone tissue regeneration, biomaterial designing, and orthopedic tissue engineering requirements. Next, we highlight the principle for orthopedic tissue engineering and describe the strategies for enhancing material Bio-functionality. Finally, we give the bench to bedside concept and concluding remarks with a special focus on future. The main purpose of current paper is to give a comprehensive overview, which is helpful for the researcher to distill this information and design future research strategies for designing materials for orthopedic and bone tissue engineering.

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Combination products: modernizing the regulatory paradigm

Cited by 19 publications

References 1 publication

Treatment Combinations for Alzheimer’s Disease: Current and Future Pharmacotherapy Options

Treatment Combinations for Alzheimer’s Disease: Current and Future Pharmacotherapy Options

Regulatory perspectives of combination products

Materials science and design principles of therapeutic materials in orthopedic and bone tissue engineering

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