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Results: 1 to 20 of 184

1.

Administrative detention of drugs intended for human or animal use. Final rule.

Food and Drug Administration, HHS.

Fed Regist. 2014 May 29;79(103):30716-21.

PMID:
24873018
[PubMed - indexed for MEDLINE]
Free Article
2.

Pediatric medical devices: a look at significant US legislation to address unmet needs.

Samuels-Reid JH, Blake ED.

Expert Rev Med Devices. 2014 Mar;11(2):169-74. doi: 10.1586/17434440.2014.864234. Epub 2014 Jan 6. Review.

PMID:
24387679
[PubMed - indexed for MEDLINE]
3.

Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals.

Riveros C, Dechartres A, Perrodeau E, Haneef R, Boutron I, Ravaud P.

PLoS Med. 2013 Dec;10(12):e1001566; discussion e1001566. doi: 10.1371/journal.pmed.1001566. Epub 2013 Dec 3.

PMID:
24311990
[PubMed - indexed for MEDLINE]
Free PMC Article
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
[PubMed - indexed for MEDLINE]
5.

Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007.

Momper JD, Mulugeta Y, Green DJ, Karesh A, Krudys KM, Sachs HC, Yao LP, Burckart GJ.

JAMA Pediatr. 2013 Oct;167(10):926-32. doi: 10.1001/jamapediatrics.2013.465.

PMID:
23921678
[PubMed - indexed for MEDLINE]
6.

Public availability of results of trials assessing cancer drugs in the United States.

Nguyen TA, Dechartres A, Belgherbi S, Ravaud P.

J Clin Oncol. 2013 Aug 20;31(24):2998-3003. doi: 10.1200/JCO.2012.46.9577. Epub 2013 Jul 22.

PMID:
23878298
[PubMed - indexed for MEDLINE]
Free Article
7.

The Food and Drug Administration Amendments Act and postmarketing commitments.

Fain K, Daubresse M, Alexander GC.

JAMA. 2013 Jul 10;310(2):202-4. doi: 10.1001/jama.2013.7900. No abstract available.

PMID:
23839755
[PubMed - indexed for MEDLINE]
8.

Orphan drug regulations. Final rule.

Food and Drug Administration, HHS.

Fed Regist. 2013 Jun 12;78(113):35117-35.

PMID:
23767079
[PubMed - indexed for MEDLINE]
Free Article
9.

Evolution of opioid risk management and review of the classwide REMS for extended-release/long-acting opioids.

Stanos S.

Phys Sportsmed. 2012 Nov;40(4):12-20. doi: 10.3810/psm.2012.11.1975. Review.

PMID:
23306411
[PubMed - indexed for MEDLINE]
10.

Transparency and the Food and Drug Administration--a quantitative study.

Lofstedt R, Bouder F, Chakraborty S.

J Health Commun. 2013;18(4):391-6. doi: 10.1080/10810730.2012.696229. Epub 2012 Nov 6. Review.

PMID:
23130648
[PubMed - indexed for MEDLINE]
11.

Risk evaluation mitigation strategies: the evolution of risk management policy.

Hollingsworth K, Toscani M.

Popul Health Manag. 2013 Apr;16(2):132-7. doi: 10.1089/pop.2012.0021. Epub 2012 Oct 31. Review.

PMID:
23113627
[PubMed - indexed for MEDLINE]
12.

The Drug Safety and Risk Management Advisory Committee: a case study of meeting frequency, content, and outcomes before and after FDAAA.

Morrato EH, Ling SB.

Med Care. 2012 Nov;50(11):970-86. doi: 10.1097/MLR.0b013e31826c872d.

PMID:
23047787
[PubMed - indexed for MEDLINE]
13.

Establishment, maintenance, and availability of records: amendment to record availability requirements. Interim final rule; request for comments.

Food and Drug Administration, HHS.

Fed Regist. 2012 Feb 23;77(36):10658-62.

PMID:
22379688
[PubMed - indexed for MEDLINE]
Free Article
14.

Further amendments to general regulations of the Food and Drug Administration to incorporate tobacco products. Final rule.

Food and Drug Administration, HHS.

Fed Regist. 2012 Feb 2;77(22):5171-6.

PMID:
22359802
[PubMed - indexed for MEDLINE]
Free Article
15.

Amendments to regulations regarding eligibility for a Medicare prescription drug subsidy. Final rule.

Social Security Administration.

Fed Regist. 2012 Jan 18;77(11):2446-8.

PMID:
22359794
[PubMed - indexed for MEDLINE]
Free Article
16.

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]
17.

Pharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed.

Nicholson S, Peterson J, Yektashenas B.

Expert Opin Drug Saf. 2012 Mar;11(2):299-314. doi: 10.1517/14740338.2012.650689. Epub 2012 Jan 10. Review.

PMID:
22233294
[PubMed - indexed for MEDLINE]
18.

Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study.

Prayle AP, Hurley MN, Smyth AR.

BMJ. 2012 Jan 3;344:d7373. doi: 10.1136/bmj.d7373.

PMID:
22214756
[PubMed - indexed for MEDLINE]
Free Article
19.

Risk evaluation and mitigation strategies (REMS): educating the prescriber.

Nicholson SC, Peterson J, Yektashenas B.

Drug Saf. 2012 Feb 1;35(2):91-104. doi: 10.2165/11597840-000000000-00000. Review.

PMID:
22171604
[PubMed - indexed for MEDLINE]
20.

College of american pathologists proposal for the oversight of laboratory-developed tests.

Vance GH.

Arch Pathol Lab Med. 2011 Nov;135(11):1432-5. doi: 10.5858/arpa.2011-0304-SA. Review.

PMID:
22032569
[PubMed - indexed for MEDLINE]

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