Evidence map›Paper›PMID 27274951›Full record

ArticleTherapeutic innovation & regulatory science2016

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013.

Gunter F Egger, Gerold T Wharton, Suzanne Malli, Jean Temeck, M Dianne Murphy, Paolo Tomasi

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic innovation & regulatory science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
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  5. Review
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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

6 authors.

Gunter F EggerEuropean Medicines Agency, London, United Kingdom.
Gerold T WhartonUS Food and Drug Administration, Silver Spring, MD, USA.
Suzanne MalliUS Food and Drug Administration, Silver Spring, MD, USA.
Jean TemeckUS Food and Drug Administration, Silver Spring, MD, USA.
M Dianne MurphyUS Food and Drug Administration, Silver Spring, MD, USA.
Paolo TomasiEuropean Medicines Agency, London, United Kingdom.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

backgroundThe European Union and the United States have different legal frameworks in place for pediatric drug development, which can potentially lead to different pediatric research requirements for the pharmaceutical industry. This manuscript compares pediatric clinical trial waivers granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

methodsThis is a retrospective review comparing EMA's Paediatric Committee (PDCO) decisions with FDA's Pediatric Review Committee (PeRC) recommendations for all product-specific pediatric full waiver applications submitted to EMA from January 2007 through December 2013. Using baseline data from EMA, we matched product-specific waivers with their FDA equivalents during the study period.

resultsFor single active substance products, PDCO and PeRC adopted similar opinions in 42 of 49 indications (86%). For fixed-dose combinations, PDCO and PeRC adopted similar opinions in 24 of 31 indications (77%).

conclusionDespite the different legal frameworks, criteria, and processes of determination, the waiver decisions of the 2 agencies were similar in the majority of cases.

Indexed as

Best Pharmaceuticals for Children Actdrug regulation in childrenPaediatric Committee (PDCO)Pediatric RegulationPediatric Research Equity ActPediatric Review Committee (PeRC)

Identifiers

PMID27274951
PMCPMC4886500

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Registered trials

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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.