Evidence map›Paper›PMID 26871618›Full record

ArticleJournal of women's health (2002)2016

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update.

Merina Elahi, Noha Eshera, Nkosazana Bambata, Helen Barr, Beverly Lyn-Cook, Julie Beitz, Maria Rios, Deborah R Taylor, Marilyn Lightfoote, Nada Hanafi and 5 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of women's health (2002), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Article
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

15 authors.

Merina Elahi1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
Noha Eshera1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
Nkosazana Bambata1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
Helen Barr2 Center for Devices and Radiological Health (CDRH) , Food and Drug Administration, Silver Spring, Maryland.
Beverly Lyn-Cook3 National Center for Toxicological Research (NCTR) , Food and Drug Administration, Jefferson, Arkansas.
Julie Beitz4 Center for Drug Evaluation and Research (CDER) , Food and Drug Administration, Silver Spring, Maryland.
Maria Rios5 Center for Biologics Evaluation and Research (CBER) , Food and Drug Administration, Silver Spring, Maryland.
Deborah R Taylor5 Center for Biologics Evaluation and Research (CBER) , Food and Drug Administration, Silver Spring, Maryland.
Marilyn Lightfoote2 Center for Devices and Radiological Health (CDRH) , Food and Drug Administration, Silver Spring, Maryland.
Nada Hanafi2 Center for Devices and Radiological Health (CDRH) , Food and Drug Administration, Silver Spring, Maryland.
Lowri DeJager6 Center for Food Safety and Applied Nutrition (CFSAN) , Food and Drug Administration, Silver Spring, Maryland.
Paddy Wiesenfeld6 Center for Food Safety and Applied Nutrition (CFSAN) , Food and Drug Administration, Silver Spring, Maryland.
Pamela E Scott1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
Emmanuel O Fadiran1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
Marsha B Henderson1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products.

Indexed as

Health PolicyScienceUnited States Food and Drug AdministrationWomen's HealthFemaleHumansPolicy MakingPregnancyUnited States

Identifiers

PMID26871618
PMCPMC4790210

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.