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Results: 1 to 20 of 22

1.

Adaptive licensing: taking the next step in the evolution of drug approval.

Eichler HG, Oye K, Baird LG, Abadie E, Brown J, Drum CL, Ferguson J, Garner S, Honig P, Hukkelhoven M, Lim JC, Lim R, Lumpkin MM, Neil G, O'Rourke B, Pezalla E, Shoda D, Seyfert-Margolis V, Sigal EV, Sobotka J, Tan D, Unger TF, Hirsch G.

Clin Pharmacol Ther. 2012 Mar;91(3):426-37. doi: 10.1038/clpt.2011.345. Epub 2012 Feb 15. Review.

PMID:
22336591
[PubMed - indexed for MEDLINE]
2.

Risk management frameworks for human health and environmental risks.

Jardine C, Hrudey S, Shortreed J, Craig L, Krewski D, Furgal C, McColl S.

J Toxicol Environ Health B Crit Rev. 2003 Nov-Dec;6(6):569-720. Review.

PMID:
14698953
[PubMed - indexed for MEDLINE]
3.

Utilization of electronic resources in the NDA/BLA regulatory review of bioanalytical data: perspectives from US FDA reviewers.

Au S, Yu C, Booth B.

Bioanalysis. 2011 Jul;3(13):1441-5. doi: 10.4155/bio.11.150. Review.

PMID:
21728769
[PubMed - indexed for MEDLINE]
4.

Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

Eichler HG, Bloechl-Daum B, Abadie E, Barnett D, König F, Pearson S.

Nat Rev Drug Discov. 2010 Apr;9(4):277-91. doi: 10.1038/nrd3079. Epub 2010 Feb 26. Review.

PMID:
20186141
[PubMed - indexed for MEDLINE]
5.

New adjuvants: EU regulatory developments.

Sesardic D, Rijpkema S, Patel BP.

Expert Rev Vaccines. 2007 Oct;6(5):849-61. Review.

PMID:
17931163
[PubMed - indexed for MEDLINE]
6.

Trends in development and approval times for new therapeutics in the United States.

Reichert JM.

Nat Rev Drug Discov. 2003 Sep;2(9):695-702. Review.

PMID:
12951576
[PubMed - indexed for MEDLINE]
7.

The evolution and effectiveness of graduated licensing.

Simpson HM.

J Safety Res. 2003 Jan;34(1):25-34. Review.

PMID:
12535903
[PubMed - indexed for MEDLINE]
8.

Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products.

Stegemann S, Klebovich I, Antal I, Blume HH, Magyar K, Németh G, Paál TL, Stumptner W, Thaler G, Van de Putte A, Shah VP.

Eur J Pharm Sci. 2011 Nov 20;44(4):447-54. doi: 10.1016/j.ejps.2011.09.012. Epub 2011 Sep 24. Review.

PMID:
21968337
[PubMed - indexed for MEDLINE]
9.

Emerging licensing issues in Canada and the US.

[No authors listed]

Int Nurs Rev. 1996 Jul-Aug;43(4):113-20, 126. Review.

PMID:
8840209
[PubMed - indexed for MEDLINE]
10.

Funding the unfundable: mechanisms for managing uncertainty in decisions on the introduction of new and innovative technologies into healthcare systems.

Stafinski T, McCabe CJ, Menon D.

Pharmacoeconomics. 2010;28(2):113-42. doi: 10.2165/11530820-000000000-00000. Review.

PMID:
20085389
[PubMed - indexed for MEDLINE]
11.

Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation.

Cohen MH.

Dermatol Ther. 2003;16(2):77-84. Review.

PMID:
12919107
[PubMed - indexed for MEDLINE]
12.

Guidelines for evaluating the efficacy and safety of live anticoccidial vaccines, and obtaining approval for their use in chickens and turkeys.

Chapman HD, Roberts B, Shirley MW, Williams RB.

Avian Pathol. 2005 Aug;34(4):279-90. Review.

PMID:
16147563
[PubMed - indexed for MEDLINE]
13.

Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.

Harapanhalli RS.

Semin Nucl Med. 2010 Sep;40(5):364-84. doi: 10.1053/j.semnuclmed.2010.05.002. Review.

PMID:
20674596
[PubMed - indexed for MEDLINE]
14.

Understanding the scientific issues embedded in the generic drug approval process.

Welage LS, Kirking DM, Ascione FJ, Gaither CA.

J Am Pharm Assoc (Wash). 2001 Nov-Dec;41(6):856-67. Review.

PMID:
11765111
[PubMed - indexed for MEDLINE]
15.

Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle.

Taylor RS, Drummond MF, Salkeld G, Sullivan SD.

BMJ. 2004 Oct 23;329(7472):972-5. Review. No abstract available.

PMID:
15499118
[PubMed - indexed for MEDLINE]
Free PMC Article
16.

Assuring the quality, safety, and efficacy of DNA vaccines.

Robertson JS, Griffiths E.

Methods Mol Med. 2006;127:363-74. Review.

PMID:
16988466
[PubMed - indexed for MEDLINE]
17.

A common policy framework for evidence generation on promising health technologies.

Carbonneil C, Quentin F, Lee-Robin SH; European network for Health Technology Assessment (EUnetHTA).

Int J Technol Assess Health Care. 2009 Dec;25 Suppl 2:56-67. doi: 10.1017/S0266462309990699. Review.

PMID:
20030892
[PubMed - indexed for MEDLINE]
18.

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
[PubMed - indexed for MEDLINE]
Free Article
19.

INGN 201: Ad-p53, Ad5CMV-p53, adenoviral p53, p53 gene therapy--introgen, RPR/INGN 201.

[No authors listed]

Drugs R D. 2007;8(3):176-87. Review.

PMID:
17472413
[PubMed - indexed for MEDLINE]
20.

Promoting, improving and accelerating the drug development and approval processes.

Graul AI.

Drug News Perspect. 2008 Jan-Feb;21(1):36-43. Review.

PMID:
18301808
[PubMed - indexed for MEDLINE]

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