Evidence map›Paper›PMID 34050010›Full record

ArticleProceedings of the National Academy of Sciences of the United States of America2021

CRISPR, animals, and FDA oversight: Building a path to success.

Laura R Epstein, Stella S Lee, Mayumi F Miller, Heather A Lombardi

Open access · greenAbstract read
In one paragraph

Article in Proceedings of the National Academy of Sciences of the United States of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 29% 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

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Cell and Gene Therapy in Equine Ocular Disease.Veterinary ophthalmology · 2026
    Review
  2. Article
  3. Review
  4. CRISPR-Cas9 in the Tailoring of Genetically Engineered Animals.Current issues in molecular biology · 2025
    Review
  5. Article
  6. Review
  7. Article
  8. Life 2.0-A CRISPR path to a sustainable planet.Proceedings of the National Academy of Sciences of the United States of America · 2021
    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

4 authors at 1 institution in 1 country.

Laura R EpsteinOffice of the Director, Center for Veterinary Medicine, US Food and Drug Administration, Rockville, MD 20855.ORCID 0000-0001-5000-4497
Stella S LeeOffice of New Animal Drug Evaluation, Center for Veterinary Medicine, US Food and Drug Administration, Rockville, MD 20855.ORCID 0000-0002-2629-2422
Mayumi F MillerOffice of Research, Center for Veterinary Medicine, US Food and Drug Administration, Laurel, MD 20708.ORCID 0000-0002-3794-7463
Heather A LombardiOffice of New Animal Drug Evaluation, Center for Veterinary Medicine, US Food and Drug Administration, Rockville, MD 20855; heather.lombardi@fda.hhs.gov.
Center for Veterinary Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Technological advances, such as genome editing and specifically CRISPR, offer exciting promise for the creation of products that address public health concerns, such as disease transmission and a sustainable food supply and enable production of human therapeutics, such as organs and tissues for xenotransplantation or recombinant human proteins to treat disease. The Food and Drug Administration recognizes the need for such innovative solutions and plays a key role in bringing safe and effective animal biotechnology products to the marketplace. In this article, we (the Food and Drug Administration/Center for Veterinary Medicine) describe the current state of the science, including advances in technology as well as scientific limitations and considerations for how researchers and commercial developers working to create intentional genomic alterations in animals can work within these limitations. We also describe our risk-based approach and how it strikes a balance between our regulatory responsibilities and the need to get innovative products to market efficiently. We continue to seek input from our stakeholders and hope to use this feedback to improve the transparency, predictability, and efficiency of our process. We think that working together, using appropriate science- and risk-based oversight, is the foundation to a successful path forward.

Indexed as

Animals, Genetically ModifiedBiomedical ResearchCRISPR-Cas SystemsGene EditingAnimalsHumansUnited StatesUnited States Food and Drug AdministrationanimalsCRISPRCVMFDAgenome editing

Identifiers

PMID34050010
PMCPMC8179205
OpenAlexW3165684196

What OpenQuestion holds

Textmetadata
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.