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Results: 1 to 20 of 137

1.

Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership.

Stang PE, Ryan PB, Racoosin JA, Overhage JM, Hartzema AG, Reich C, Welebob E, Scarnecchia T, Woodcock J.

Ann Intern Med. 2010 Nov 2;153(9):600-6. doi: 10.7326/0003-4819-153-9-201011020-00010.

PMID:
21041580
[PubMed - indexed for MEDLINE]
2.

The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction.

Platt R, Carnahan RM, Brown JS, Chrischilles E, Curtis LH, Hennessy S, Nelson JC, Racoosin JA, Robb M, Schneeweiss S, Toh S, Weiner MG.

Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:1-8. doi: 10.1002/pds.2343.

PMID:
22262586
[PubMed - indexed for MEDLINE]
3.
4.

Active surveillance of postmarket medical product safety in the Federal Partners' Collaboration.

Robb MA, Racoosin JA, Worrall C, Chapman S, Coster T, Cunningham FE.

Med Care. 2012 Nov;50(11):948-53. doi: 10.1097/MLR.0b013e31826c874d.

PMID:
23047784
[PubMed - indexed for MEDLINE]
5.
6.

Manufacturer's drug interaction and postmarketing adverse event data: what are appropriate uses?

Kraft WK, Waldman SA.

Drug Saf. 2001;24(9):637-43. Review.

PMID:
11522118
[PubMed - indexed for MEDLINE]
8.

Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers.

Bennett CL, Nebeker JR, Yarnold PR, Tigue CC, Dorr DA, McKoy JM, Edwards BJ, Hurdle JF, West DP, Lau DT, Angelotta C, Weitzman SA, Belknap SM, Djulbegovic B, Tallman MS, Kuzel TM, Benson AB, Evens A, Trifilio SM, Courtney DM, Raisch DW.

Arch Intern Med. 2007 May 28;167(10):1041-9.

PMID:
17533207
[PubMed - indexed for MEDLINE]
9.

The role of academia and the research community in assisting the Food and Drug Administration to ensure U.S. drug safety.

Lo Re V 3rd, Strom BL.

Pharmacoepidemiol Drug Saf. 2007 Jul;16(7):818-25.

PMID:
17436357
[PubMed - indexed for MEDLINE]
10.

Design considerations, architecture, and use of the Mini-Sentinel distributed data system.

Curtis LH, Weiner MG, Boudreau DM, Cooper WO, Daniel GW, Nair VP, Raebel MA, Beaulieu NU, Rosofsky R, Woodworth TS, Brown JS.

Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:23-31. doi: 10.1002/pds.2336.

PMID:
22262590
[PubMed - indexed for MEDLINE]
11.

Medical device vigilance at FDA.

Gross TP, Kessler LG.

Stud Health Technol Inform. 1996;28:17-24.

PMID:
10164091
[PubMed - indexed for MEDLINE]
12.

Fostering innovation, advancing patient safety: the kidney health initiative.

Archdeacon P, Shaffer RN, Winkelmayer WC, Falk RJ, Roy-Chaudhury P.

Clin J Am Soc Nephrol. 2013 Sep;8(9):1609-17. doi: 10.2215/CJN.01140113. Epub 2013 Jun 6.

PMID:
23744001
[PubMed - indexed for MEDLINE]
13.

The impact of FDA reform.

Trunzo J.

Med Device Technol. 2003 Apr;14(3):36-7.

PMID:
12789699
[PubMed - indexed for MEDLINE]
14.

The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise.

Nguyen M, Ball R, Midthun K, Lieu TA.

Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:291-7. doi: 10.1002/pds.2323.

PMID:
22262619
[PubMed - indexed for MEDLINE]
15.

Reply to "Can the Institute of Medicine review the FDA?".

Fineberg HV.

Nat Med. 2005 Jun;11(6):589. No abstract available.

PMID:
15937463
[PubMed - indexed for MEDLINE]
16.

Remarks of the Acting FDA Commissioner: FDLI's 48th annual conference.

Crawford LM.

Food Drug Law J. 2005;60(2):99-102. No abstract available.

PMID:
16097087
[PubMed - indexed for MEDLINE]
17.

A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.

Allan MC.

J Pharm Technol. 1992 Sep-Oct;8(5):198-202. Review.

PMID:
10171208
[PubMed - indexed for MEDLINE]
18.

User fees and beyond--the FDA Safety and Innovation Act of 2012.

Kramer DB, Kesselheim AS.

N Engl J Med. 2012 Oct 4;367(14):1277-9. doi: 10.1056/NEJMp1207800. No abstract available.

PMID:
23034017
[PubMed - indexed for MEDLINE]
Free Article
19.

Pharmaceuticals and medical devices: FDA oversight. Issue brief.

Berry MD.

Issue Brief Health Policy Track Serv. 2012 Dec 31:1-79. No abstract available.

PMID:
23297449
[PubMed - indexed for MEDLINE]
20.

Value of unique device identification in the digital health infrastructure.

Wilson NA, Drozda J.

JAMA. 2013 May 22;309(20):2107-8. doi: 10.1001/jama.2013.5514. No abstract available.

PMID:
23695480
[PubMed - indexed for MEDLINE]

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