This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features!

Skip to main page content

Email citation

Add to Collections

Your saved search

Name of saved search:

Search terms:

Test search terms

Would you like email updates of new search results?

Yes
No

Email: (change)

Frequency:

Which day?

Which day?

Report format:

Send at most:

Send even when there aren't any new results

Optional text in email:

Your RSS Feed

Editorial

. 2023 Sep;136(9):853-854.

doi: 10.1016/j.amjmed.2023.03.033. Epub 2023 Apr 18.

The FDA Modernization Act 2.0: Drug Testing in Animals is Rendered Optional

Eli Y Adashi¹, Daniel P O'Mahony², I Glenn Cohen³

Affiliations

Affiliations

¹ Department of Medicine and Biological Sciences [Former Dean], Brown University, Providence, RI. Electronic address: eli_adashi@brown.edu.
² Library Planning and Assessment, Brown University Library, Providence, RI.
³ Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Harvard University, Cambridge, Mass.

PMID: 37080328
DOI: 10.1016/j.amjmed.2023.03.033

Editorial

The FDA Modernization Act 2.0: Drug Testing in Animals is Rendered Optional

Eli Y Adashi et al. Am J Med. 2023 Sep.

. 2023 Sep;136(9):853-854.

doi: 10.1016/j.amjmed.2023.03.033. Epub 2023 Apr 18.

Authors

Eli Y Adashi¹, Daniel P O'Mahony², I Glenn Cohen³

Affiliations

¹ Department of Medicine and Biological Sciences [Former Dean], Brown University, Providence, RI. Electronic address: eli_adashi@brown.edu.
² Library Planning and Assessment, Brown University Library, Providence, RI.
³ Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Harvard University, Cambridge, Mass.

PMID: 37080328
DOI: 10.1016/j.amjmed.2023.03.033

No abstract available

PubMed Disclaimer

Similar articles

Will FDA relinquish the "gold standard" for new drug approval? Redefining "substantial evidence" in the FDA Modernization Act of 1997.
Kulynych J. Kulynych J. Food Drug Law J. 1999;54(1):127-49. Food Drug Law J. 1999. PMID: 11758555 No abstract available.
FDA Modernization Act 2.0: An insight from nondeveloping country.
Akash SR, Arnob MAJB, Uddin MJ. Akash SR, et al. Drug Dev Res. 2023 Dec;84(8):1572-1577. doi: 10.1002/ddr.22108. Epub 2023 Aug 17. Drug Dev Res. 2023. PMID: 37587871
The US Food and Drug Administration Modernization Act of 1997: impact on consumers.
Golodner LF. Golodner LF. Clin Ther. 1998;20 Suppl C:C20-5. doi: 10.1016/s0149-2918(98)80004-0. Clin Ther. 1998. PMID: 9915086 Review.
List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness--FDA. Proposed rule.
[No authors listed] [No authors listed] Fed Regist. 1998 Oct 8;63(195):54082-9. Fed Regist. 1998. PMID: 10185826
Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.
Harapanhalli RS. Harapanhalli RS. Semin Nucl Med. 2010 Sep;40(5):364-84. doi: 10.1053/j.semnuclmed.2010.05.002. Semin Nucl Med. 2010. PMID: 20674596 Review.

See all similar articles

Cited by

Development of an Oral Epithelial Ex Vivo Organ Culture Model for Biocompatibility and Permeability Assessment of Biomaterials.
Machla F, Bekiari C, Monou PK, Kofidou E, Theodosaki AM, Katsamenis OL, Zisis V, Kokoti M, Bakopoulou A, Fatouros D, Andreadis D. Machla F, et al. Bioengineering (Basel). 2024 Oct 17;11(10):1035. doi: 10.3390/bioengineering11101035. Bioengineering (Basel). 2024. PMID: 39451410 Free PMC article.
Improving the predictive power of mouse models.
Pera M, Greene A, Cardon L, Carter GW, Chesler EJ, Churchill G, Kumar V, Lutz C, Munger S, Murray S, O'Connell K, Reinholdt L, Rosenthal NA. Pera M, et al. Nat Biotechnol. 2024 Aug;42(8):1175-1177. doi: 10.1038/s41587-024-02349-2. Nat Biotechnol. 2024. PMID: 39143158 No abstract available.
Bridging the Gap: Integrating 3D Bioprinting and Microfluidics for Advanced Multi-Organ Models in Biomedical Research.
De Spirito M, Palmieri V, Perini G, Papi M. De Spirito M, et al. Bioengineering (Basel). 2024 Jun 28;11(7):664. doi: 10.3390/bioengineering11070664. Bioengineering (Basel). 2024. PMID: 39061746 Free PMC article.
In vitro to in vivo extrapolation from 3D hiPSC-derived cardiac microtissues and physiologically based pharmacokinetic modeling to inform next-generation arrhythmia risk assessment.
Daley MC, Moreau M, Bronk P, Fisher J, Kofron CM, Mende U, McMullen P, Choi BR, Coulombe K. Daley MC, et al. Toxicol Sci. 2024 Sep 1;201(1):145-157. doi: 10.1093/toxsci/kfae079. Toxicol Sci. 2024. PMID: 38897660
Advances in high throughput cell culture technologies for therapeutic screening and biological discovery applications.
Ryoo H, Kimmel H, Rondo E, Underhill GH. Ryoo H, et al. Bioeng Transl Med. 2023 Dec 4;9(3):e10627. doi: 10.1002/btm2.10627. eCollection 2024 May. Bioeng Transl Med. 2023. PMID: 38818120 Free PMC article. Review.

See all "Cited by" articles

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
- ClinicalKey
- Elsevier Science