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Items: 1 to 20 of 167

1.

Recent new drug approvals. Part 1: drugs with pediatric indications.

Shelton CM, Chhim RF, Christensen ML.

J Pediatr Pharmacol Ther. 2012 Oct;17(4):329-39. doi: 10.5863/1551-6776-17.4.329.

2.

Recent new drug approvals, part 2: drugs undergoing active clinical studies in children.

Chhim RF, Shelton CM, Christensen ML.

J Pediatr Pharmacol Ther. 2013 Jan;18(1):14-38. doi: 10.5863/1551-6776-18.1.14.

3.

Regulatory approvals of pediatric oncology drugs: previous experience and new initiatives.

Hirschfeld S, Ho PT, Smith M, Pazdur R.

J Clin Oncol. 2003 Mar 15;21(6):1066-73. Epub 2003 Feb 7. Review.

PMID:
12637472
4.

Status of drug approval processes and regulation of medications for children.

Kauffman RE.

Curr Opin Pediatr. 1995 Apr;7(2):195-8.

PMID:
7787936
5.

Food and Drug Administration approval for medications used in the pediatric intensive care unit: a continuing conundrum.

Yang CP, Veltri MA, Anton B, Yaster M, Berkowitz ID.

Pediatr Crit Care Med. 2011 Sep;12(5):e195-9. doi: 10.1097/PCC.0b013e3181fe25b9.

PMID:
21057369
7.

IOM Review of FDA--approved biologics labeled or studied for pediatric use.

Field MJ, Ellinger LK, Boat TF.

Pediatrics. 2013 Feb;131(2):328-35. doi: 10.1542/peds.2012-2412. Epub 2013 Jan 14. Review.

8.

Pediatric use of topical ophthalmic drugs.

Coulter RA.

Optometry. 2004 Jul;75(7):419-29. Review.

PMID:
15296375
9.

Drug-review deadlines and safety problems.

Carpenter D, Zucker EJ, Avorn J.

N Engl J Med. 2008 Mar 27;358(13):1354-61. doi: 10.1056/NEJMsa0706341.

10.

Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

Sridhara R, Johnson JR, Justice R, Keegan P, Chakravarty A, Pazdur R.

J Natl Cancer Inst. 2010 Feb 24;102(4):230-43. doi: 10.1093/jnci/djp515. Epub 2010 Jan 29. Review. Erratum in: J Natl Cancer Inst. 2010 Apr 21;102(8):578-9.

PMID:
20118413
11.

U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States.

Wing DA, Powers B, Hickok D.

Obstet Gynecol. 2010 Apr;115(4):825-33. doi: 10.1097/AOG.0b013e3181d53843.

PMID:
20308845
12.

Ultimate fate of oncology drugs approved by the us food and drug administration without a randomized Trial.

Tsimberidou AM, Braiteh F, Stewart DJ, Kurzrock R.

J Clin Oncol. 2009 Dec 20;27(36):6243-50. doi: 10.1200/JCO.2009.23.6018. Epub 2009 Oct 13. Review.

PMID:
19826112
13.

The new drug approvals of 1993, 1994, and 1995: trends in drug development.

Kaitin KI, Manocchia M.

Am J Ther. 1997 Jan;4(1):46-54.

PMID:
10423591
15.

The new drug approvals of 1990, 1991, and 1992: trends in drug development.

Kaitin KI, Manocchia M, Seibring M, Lasagna L.

J Clin Pharmacol. 1994 Feb;34(2):120-7.

PMID:
8163711
16.

New indications for already-approved drugs: an analysis of regulatory review times.

DiMasi JA, Kaitin KI, Fernandez-Carol C, Lasagna L.

J Clin Pharmacol. 1991 Mar;31(3):205-15.

PMID:
2019661
17.

Recent drug approvals from the US FDA and EMEA: what the future holds.

Pevarello P.

Future Med Chem. 2009 Apr;1(1):35-48. doi: 10.4155/fmc.09.8.

PMID:
21426069
18.

Pediatric oncology: regulatory initiatives.

Hirschfeld S, Shapiro A, Dagher R, Pazdur R.

Oncologist. 2000;5(6):441-4.

19.

Trends in drug development: the 1985-86 new drug approvals.

Kaitin KI, Richard BW, Lasagna L.

J Clin Pharmacol. 1987 Aug;27(8):542-8.

PMID:
3655005
20.

Keeping up with current drug approvals.

Kupecz D.

Nurse Pract. 1999 Feb;24(2):44-8, 54, 56-7; quiz 58-9. Review.

PMID:
10048078

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