Evidence map›Paper›PMID 34901562›Full record

ReviewBioactive materials2022

Regulatory perspectives of combination products.

Jiaxin Tian, Xu Song, Yongqing Wang, Maobo Cheng, Shuang Lu, Wei Xu, Guobiao Gao, Lei Sun, Zhonglan Tang, Minghui Wang and 1 more

Open access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Bioactive materials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 49 citations in OpenAlex.

  1. Review
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  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Smart Catheters for Diagnosis, Monitoring, and Therapy.Advanced healthcare materials · 2026
    Review
  12. Review
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  14. Review
  15. Review
  16. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Jiaxin TianCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Xu SongNMPA Key Laboratory for Quality Research and Control of Tissue Regenerative Biomaterial & Institute of Regulatory Science for Medical Devices & NMPA Research Base of Regulatory Science for Medical Devices, Sichuan University, Chengdu, China.
Yongqing WangCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Maobo ChengCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Shuang LuCenter for Drug Evaluation, National Medical Products Administration, Beijing, China.
Wei XuCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Guobiao GaoCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Lei SunCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Zhonglan TangNMPA Key Laboratory for Quality Research and Control of Tissue Regenerative Biomaterial & Institute of Regulatory Science for Medical Devices & NMPA Research Base of Regulatory Science for Medical Devices, Sichuan University, Chengdu, China.
Minghui WangNMPA Key Laboratory for Quality Research and Control of Tissue Regenerative Biomaterial & Institute of Regulatory Science for Medical Devices & NMPA Research Base of Regulatory Science for Medical Devices, Sichuan University, Chengdu, China.
Xingdong ZhangNMPA Key Laboratory for Quality Research and Control of Tissue Regenerative Biomaterial & Institute of Regulatory Science for Medical Devices & NMPA Research Base of Regulatory Science for Medical Devices, Sichuan University, Chengdu, China.
National Medical Products Administration · CNSichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Combination productsDefinitionDesignationRegulatory scienceSafety and efficacy

Identifiers

PMID34901562
PMCPMC8637005
OpenAlexW3197294348

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.