Evidence map›Paper›PMID 40109724›Full record

ReviewFrontiers in medicine2025

Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks.

Francisco D Rodríguez-Gómez, Dominique Monferrer, Oriol Penon, Pilar Rivera-Gil

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 papers.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed
–field-weighted citation impact
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

92 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review

32 more citing papers are in PubMed but not listed here.

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

4 authors.

Francisco D Rodríguez-GómezAsphalion SL, Barcelona, Spain.
Dominique MonferrerAsphalion SL, Barcelona, Spain.
Oriol PenonAsphalion SL, Barcelona, Spain.
Pilar Rivera-GilIntegrative Biomedical Materials and Nanomedicine Lab, Department of Medicine and Life Sciences, Universitat Pompeu Fabra Barcelona Biomedicine Research Park (PRBB) Doctor Aiguader, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The integration of nanotechnology into healthcare has introduced Nanotechnology-Enabled Health Products (NHPs), promising revolutionary advancements in medical treatments and diagnostics. Despite their potential, the regulatory navigation for these products remains complex and often lagging, creating barriers to their clinical application. This review article focuses on dissecting the regulatory landscape for NHPs, particularly in the European Union and the United States, to identify applicable requirements and the main regulatory guidelines currently available for meeting regulatory expectations.

Indexed as

European Unionhealthcare innovationmedical regulationsnanotechnology-enabled health productsregulatory pathwaysUnited States

Identifiers

PMID40109724
PMCPMC11919859

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.