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Items: 1 to 20 of 247

1.

Safety monitoring of drugs receiving pediatric marketing exclusivity.

Smith PB, Benjamin DK Jr, Murphy MD, Johann-Liang R, Iyasu S, Gould B, Califf RM, Li JS, Rodriguez W.

Pediatrics. 2008 Sep;122(3):e628-33. doi: 10.1542/peds.2008-0585.

2.

FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007-2013.

Cope JU, Rosenthal GL, Weinel P, Odegaard A, Murphy DM.

Pediatrics. 2015 Dec;136(6):1125-31. doi: 10.1542/peds.2015-0469. Review.

3.

Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.

Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT.

MMWR Surveill Summ. 2003 Jan 24;52(1):1-24. Erratum in: MMWR Morb Mortal Wkly Rep. 2003 Feb 14;52(06):113.

4.

Pediatric exclusivity: evolving legislation and novel complexities within pediatric therapeutic development.

Rivera DR, Hartzema AG.

Ann Pharmacother. 2014 Mar;48(3):369-79. doi: 10.1177/1060028013514031. Epub 2013 Dec 5. Review.

PMID:
24311725
5.
6.

Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.

Wharton GT, Murphy MD, Avant D, Goldsmith JV, Chai G, Rodriguez WJ, Eisenstein EL.

Pediatrics. 2014 Aug;134(2):e512-8. doi: 10.1542/peds.2013-2987. Epub 2014 Jul 14.

7.
8.

Pediatric drug labeling: improving the safety and efficacy of pediatric therapies.

Roberts R, Rodriguez W, Murphy D, Crescenzi T.

JAMA. 2003 Aug 20;290(7):905-11.

PMID:
12928467
9.

Prescription-event monitoring and reporting of adverse drug reactions.

Heeley E, Riley J, Layton D, Wilton LV, Shakir SA.

Lancet. 2001 Dec 1;358(9296):1872-3.

PMID:
11741629
10.

IOM: overhaul drug safety monitoring.

Kuehn BM.

JAMA. 2006 Nov 1;296(17):2075-6. No abstract available.

PMID:
17077364
11.

Pediatric post-marketing safety systems in North America: assessment of the current status.

McMahon AW, Wharton GT, Bonnel R, DeCelle M, Swank K, Testoni D, Cope JU, Smith PB, Wu E, Murphy MD.

Pharmacoepidemiol Drug Saf. 2015 Aug;24(8):785-92. doi: 10.1002/pds.3813. Epub 2015 Jun 22. Review. Erratum in: Pharmacoepidemiol Drug Saf. 2016 Jan;25(1):110-1.

PMID:
26098297
12.

Protecting the health of the public--Institute of Medicine recommendations on drug safety.

Psaty BM, Burke SP.

N Engl J Med. 2006 Oct 26;355(17):1753-5. Epub 2006 Oct 9. No abstract available.

14.

Methods for retrospective detection of drug safety signals and adverse events in electronic general practice records.

Tomlin A, Reith D, Dovey S, Tilyard M.

Drug Saf. 2012 Sep 1;35(9):733-43. doi: 10.2165/11631970-000000000-00000.

PMID:
22861670
15.

Economic return of clinical trials performed under the pediatric exclusivity program.

Li JS, Eisenstein EL, Grabowski HG, Reid ED, Mangum B, Schulman KA, Goldsmith JV, Murphy MD, Califf RM, Benjamin DK Jr.

JAMA. 2007 Feb 7;297(5):480-8.

16.

Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

Cook DM, Gurugubelli RK, Bero LA.

Drug Saf. 2009;32(11):1057-66. doi: 10.2165/11316670-000000000-00000.

PMID:
19810777
17.

Development, testing, and findings of a pediatric-focused trigger tool to identify medication-related harm in US children's hospitals.

Takata GS, Mason W, Taketomo C, Logsdon T, Sharek PJ.

Pediatrics. 2008 Apr;121(4):e927-35. doi: 10.1542/peds.2007-1779.

PMID:
18381521
19.

Peer-reviewed publication of clinical trials completed for pediatric exclusivity.

Benjamin DK Jr, Smith PB, Murphy MD, Roberts R, Mathis L, Avant D, Califf RM, Li JS.

JAMA. 2006 Sep 13;296(10):1266-73.

20.

Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project.

de Bie S, Ferrajolo C, Straus SM, Verhamme KM, Bonhoeffer J, Wong IC, Sturkenboom MC; GRiP network..

PLoS One. 2015 Jun 19;10(6):e0130399. doi: 10.1371/journal.pone.0130399. eCollection 2015.

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