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Items: 1 to 20 of 104

1.

The US Food and Drug Administration provides a pathway for licensing vaccines for global diseases.

Brennan MJ.

PLoS Med. 2009 Jul 21;6(7):e1000095. doi: 10.1371/journal.pmed.1000095. Epub 2009 Jul 21. No abstract available.

2.

Food and Drug Administration regulation and evaluation of vaccines.

Marshall V, Baylor NW.

Pediatrics. 2011 May;127 Suppl 1:S23-30. doi: 10.1542/peds.2010-1722E. Epub 2011 Apr 18. Review.

PMID:
21502242
3.

Vaccines in the pipeline: the path from development to use in the United States.

Pickering LK, Walton LR.

Pediatr Ann. 2013 Aug;42(8):146-52. doi: 10.3928/00904481-20130723-08. Review.

PMID:
23910027
4.

US regulation of combination products.

Donawa M.

Med Device Technol. 2009 Oct;20(6):22, 24-5.

PMID:
20302139
5.

US FDA review and regulation of preventive vaccines for infectious disease indications: impact of the FDA Amendments Act 2007.

Gruber MF.

Expert Rev Vaccines. 2011 Jul;10(7):1011-9. doi: 10.1586/erv.11.52. Review.

PMID:
21806396
6.

They are from the government and they really are here to help you.

Woosley RL.

J Clin Pharmacol. 2008 Feb;48(2):142-3. doi: 10.1177/0091270007313559. No abstract available.

PMID:
18199889
7.

Communicating with the FDA: the "third rail" of a new model for drug development.

Stanski DR, Orloff JJ.

J Clin Pharmacol. 2008 Feb;48(2):144-5. doi: 10.1177/0091270007313560. No abstract available.

PMID:
18199890
8.
9.

FDA is criticised for licensing high dose donepezil.

Lenzer J.

BMJ. 2011 May 25;342:d3270. doi: 10.1136/bmj.d3270. No abstract available.

PMID:
21613347
10.

Trends in US approvals: new biopharmaceuticals and vaccines.

Reichert JM.

Trends Biotechnol. 2006 Jul;24(7):293-8. Epub 2006 Jun 6.

PMID:
16759723
11.

Pharmaceutical and Medical Devices: FDA Oversight.

White RS; Thomson Reuters Accelus..

Issue Brief Health Policy Track Serv. 2015 Dec 28:1-97. No abstract available.

PMID:
27116797
12.

Legal preparation and pandemic influenza.

De Ville K.

J Public Health Manag Pract. 2007 May-Jun;13(3):314-7. No abstract available.

PMID:
17435499
13.

The value of immunization for God's people.

Grabenstein JD.

Natl Cathol Bioeth Q. 2006 Autumn;6(3):433-42. No abstract available.

PMID:
17091550
14.

Vaccine licensure: a proposal to meet changing needs.

Robbins FC, Mortimer EA Jr.

Ann N Y Acad Sci. 1995 May 31;754:368-76. No abstract available.

PMID:
7625676
15.

The 21st Century Cures Act--Will It Take Us Back in Time?

Avorn J, Kesselheim AS.

N Engl J Med. 2015 Jun 25;372(26):2473-5. doi: 10.1056/NEJMp1506964. Epub 2015 Jun 3. No abstract available.

16.

Economic and regulatory considerations in pharmacogenomics for drug licensing and healthcare.

Shah J.

Nat Biotechnol. 2003 Jul;21(7):747-53. No abstract available.

PMID:
12833092
17.

Priority review vouchers: an inefficient and dangerous way to promote neglected-disease drug development.

Kesselheim AS.

Clin Pharmacol Ther. 2009 Jun;85(6):573-5. doi: 10.1038/clpt.2009.50. No abstract available.

PMID:
19451908
18.

Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration.

Ball R, Horne D, Izurieta H, Sutherland A, Walderhaug M, Hsu H.

Pediatrics. 2011 May;127 Suppl 1:S31-8. doi: 10.1542/peds.2010-1722F. Epub 2011 Apr 18. Review.

PMID:
21502249
19.

Legal foundations of adaptive licensing.

Oye K, Baird LG, Chia A, Hocking S, Hutt PB, Lee D, Norwalk L, Salvatore V.

Clin Pharmacol Ther. 2013 Sep;94(3):309-11. doi: 10.1038/clpt.2013.95.

PMID:
23963219
20.

Changes to US drug safety laws take center stage.

Wadman M.

Nat Med. 2007 Apr;13(4):389. Epub 2007 Mar 28. No abstract available.

PMID:
17415357

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