Literature DB >> 28496147

Combination products: modernizing the regulatory paradigm.

Nina L Hunter1, Rachel E Sherman1.   

Abstract

New opportunities to develop innovative - and often complex - products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible and consistent science-based regulatory approach for combination products.

Mesh:

Year:  2017        PMID: 28496147     DOI: 10.1038/nrd.2017.66

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN: 1474-1776            Impact factor:   84.694


  1 in total

1.  Commensal Bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy.

Authors:  Ayelet Sivan; Leticia Corrales; Nathaniel Hubert; Jason B Williams; Keston Aquino-Michaels; Zachary M Earley; Franco W Benyamin; Yuk Man Lei; Bana Jabri; Maria-Luisa Alegre; Eugene B Chang; Thomas F Gajewski
Journal:  Science       Date:  2015-11-05       Impact factor: 47.728

  1 in total
  4 in total

1.  Tertiary patenting on drug-device combination products in the United States.

Authors:  Reed F Beall; Aaron S Kesselheim
Journal:  Nat Biotechnol       Date:  2018-02-06       Impact factor: 54.908

Review 2.  Regulatory perspectives of combination products.

Authors:  Jiaxin Tian; Xu Song; Yongqing Wang; Maobo Cheng; Shuang Lu; Wei Xu; Guobiao Gao; Lei Sun; Zhonglan Tang; Minghui Wang; Xingdong Zhang
Journal:  Bioact Mater       Date:  2021-09-07

3.  The regulatory challenges of innovative customized combination products.

Authors:  Mariana E Reis; Ana Bettencourt; Helena M Ribeiro
Journal:  Front Med (Lausanne)       Date:  2022-07-22

Review 4.  Treatment Combinations for Alzheimer's Disease: Current and Future Pharmacotherapy Options.

Authors:  Jeffrey L Cummings; Gary Tong; Clive Ballard
Journal:  J Alzheimers Dis       Date:  2019       Impact factor: 4.472

  4 in total

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