Drug Approval

Core Concepts in Pharmacology Drug Regulation and Approval
http://www.mac.edu/

Quantitative “Learning” Approaches Influence Drug Approval
Hao Zhu, Ph.D.
http://www.ncsu.edu

Human Subjects in Research
Helen Tamer
http://open.umich.edu

FDA - Introduction to Drug Regulation
Edward P. Richards
http://biotech.law.lsu.edu

Drug Development - A view on the process from the idea to the registered pharmaceutical
Dr. Matthias Kreuter
http://www.aucegypt.edu

Evolution of a New Medication
http://cstl-cla.semo.edu

Drug Disposal Labeling to Improve Safety - FDA Update on Drug Disposal Labeling Activities
James R. Hunter, R.Ph., MPH
http://www.benzos.une.edu

The Drug Approval Process
http://www.kishwaukeecollege.edu

The Role of the DMF in the FDA Approval Process
John B. Dubeck
http://www.dmfworkshop.msu.edu/

Direct-to-Consumer Advertising: Dangerous Game of Pitching Products to Parents
Lynne Wells Graziano
http://www.pitt.edu

The Food and Drug Administration: then and now
Satish R Raj MD
http://www.mc.vanderbilt.edu

Working With Pharma Sponsors In Research
Becky Hubbell
https://www2.kumc.edu

From Bench to Bedside : Getting New Drugs Approved by the FDA
Getting a New Drug Approved : The Procedure
http://www.library.health.ufl.edu

Biopharmaceutical Development & Regulation
Ron Guido
http://www.columbia.edu/

Ethics
http://www.wou.edu

Single Patient Use of Investigational Drugs - A Tutorial for UH Physicians and Staff
http://www.hawaii.edu

Evaluation & Categorization of Drugs
Frank F. Vincenzi
https://courses.washington.edu

94 Published articles on Drug Approval

1. Mullard A. 2011 FDA drug approvals. Nat Rev Drug Discov. 2012 Feb1;11(2):91-4. doi. http://dx.doi.org/10.1038/nrd3657.
2. Goozner M. Drug approvals 2011. focus on companion diagnostics. J Natl Cancer Inst. 2012 Jan 18;104(2):84-6. Epub 2012 Jan 3.
3. Lichtenberg FR. The impact of new (orphan) drug approvals on prematuremortality from rare diseases in the United States and France, 1999-2007. Eur JHealth Econ. 2011 Sep 28. [Epub ahead of print]
4. Igoe G. Drug approvals and size of prescribing pool. BMJ. 2011 Sep27;343:d6141. doi. http://dx.doi.org/10.1136/bmj.d6141.
5. Wynn RL. FDA new drug approvals in 2010. Gen Dent. 2011 Jul-Aug;59(4):250-3.
6. Sorenson C, Naci H, Cylus J, Mossialos E. Evidence of comparative efficacyshould have a formal role in European drug approvals. BMJ. 2011 Sep 6;343:d4849. doi. http://dx.doi.org/10.1136/bmj.d4849.
7. Muramatsu M, Arisue Y. [New drug approvals over three decades from 1980 to2009 in Japan--their therapeutic targets and biochemical properties]. YakugakuZasshi. 2011 Apr;131(4):603-19. Japanese.
8. Shimazawa R, Ikeda M. Japan lags behind the UK in neurological drug approvals.Br J Clin Pharmacol. 2011 Mar;71(3):473-5. doi. http://dx.doi.org/10.1111/j.1365-2125.2010.03848.x.
9. Mullard A. 2010 FDA drug approvals. Nat Rev Drug Discov. 2011 Feb;10(2):82-5.
10. Kaitin KI, DiMasi JA. Pharmaceutical innovation in the 21st century. new drugapprovals in the first decade, 2000-2009. Clin Pharmacol Ther. 2011Feb;89(2):183-8. Epub 2010 Dec 29. Review.
11. Nakade S, Kitagawa J, Ohno T, Amano C, Honda N, Kodama Y, Ogawa M. Impact of "guidance for industry. clinical pharmacokinetic studies of pharmaceuticals" onnew drug approvals of central nervous system drugs in Japan. Drug MetabPharmacokinet. 2011;26(1):117-20. Epub 2010 Oct 22.
12. Wynn RL. FDA new drug approvals in 2009. Gen Dent. 2010 Jul-Aug;58(4):280-4.
13. Hughes B. 2009 FDA drug approvals. Nat Rev Drug Discov. 2010 Feb;9(2):89-92.
14. StatBite. New drug approvals in Japan. a comparison of review times andnumber of employees. J Natl Cancer Inst. 2010 Feb 3;102(3):150. Epub 2010 Jan 27.
15. Belavic JM. Drug approvals. '09 in review. Nurse Pract. 2010 Feb;35(2):12-23;quiz 23-4. Review.
16. Coté T, Kelkar A, Xu K, Braun MM, Phillips MI. Orphan products. an emergingtrend in drug approvals. Nat Rev Drug Discov. 2010 Jan;9(1):84.
17. Enna SJ, Williams M. The decreased number of new drug approvals (NDAs) hasbeen a topic of considerable debate over the past decade. Preface. Adv Pharmacol.2009;57:xi-ii.
18. Wynn RL. FDA new drug approvals in 2008. Gen Dent. 2009 Jul-Aug;57(4):300-4.
19. Dorsey ER, Thompson JP, Carrasco M, de Roulet J, Vitticore P, Nicholson S,Johnston SC, Holloway RG, Moses H 3rd. Financing of U.S. biomedical research and new drug approvals across therapeutic areas. PLoS One. 2009 Sep 11;4(9):e7015.
20. Pevarello P. Recent drug approvals from the US FDA and EMEA. what the future holds. Future Med Chem. 2009 Apr;1(1):35-48.
21. Hughes B. 2008 FDA drug approvals. Nat Rev Drug Discov. 2009 Feb;8(2):93-6.
22. Laustsen G, Carrillo F, Johnson J, Smith C. Drug approvals. '08 in review.Ciclesonide (Alvesco). Nurse Pract. 2009 Feb;34(2):32-4.
23. Laustsen G, Carrillo F, Johnson J, Smith C. Drug approvals. '08 in review.Methylnaltrexone (Relistor). Nurse Pract. 2009 Feb;34(2):31.
24. Laustsen G, Carrillo F, Johnson J, Smith C. Drug approvals. '08 in review.Rotavirus vaccine, live, oral (Rotarix). Nurse Pract. 2009 Feb;34(2):30-1.
25. Laustsen G, Carrillo F, Johnson J, Smith C. Drug approvals. '08 in review.Olopatadine hydrochloride (Patanase) nasal spray. Nurse Pract. 2009 Feb;34(2):29.
26. Laustsen G, Carrillo F, Johnson J, Smith C. Drug approvals. '08 in review.Desvenlafaxine (Pristiq). Nurse Pract. 2009 Feb;34(2):28.
27. Laustsen G, Carrillo F, Johnson J, Smith C. Drug approvals. '08 in review.Certolizumab pegol (Cimzia). Nurse Pract. 2009 Feb;34(2):26-7.
28. Laustsen G, Carrillo F, Johnson J, Smith C. Drug approvals. '08 in review.Nebivolol (Bystolic). Nurse Pract. 2009 Feb;34(2):25-6.
29. Sipkoff M. Fibromyalgia coverage uneven despite recent drug approvals. Manag Care. 2008 Dec;17(12):9-10.
30. Wynn RL. FDA new drug approvals in 2007. Gen Dent. 2008 Sep-Oct;56(6):506-10.
31. Hughes B. 2007 FDA drug approvals. a year of flux. Nat Rev Drug Discov. 2008 Feb;7(2):107-9.
32. Anderson KC, Kyle RA, Rajkumar SV, Stewart AK, Weber D, Richardson P; ASH/FDAPanel on Clinical Endpoints in Multiple Myeloma. Clinically relevant end pointsand new drug approvals for myeloma. Leukemia. 2008 Feb;22(2):231-9. Epub 2007 Nov1.
33. Fulton A. New drug approvals. shifting the focus from speed to safety. AHIPCover. 2007 Sep-Oct;48(5):14, 66.
34. A look ahead at this year's drug approvals. Proj Inf Perspect. 2007Apr;(43):4-7.
35. Wynn RL. FDA new drug approvals in 2006. Gen Dent. 2007 Jul-Aug;55(4):275-9.
36. Atkins MB. The effect of recent drug approvals on translational research and drug development. Clin Adv Hematol Oncol. 2007 Apr;5(4):285-7. Review.
37. Avorn J. Paying for drug approvals--who's using whom? N Engl J Med. 2007 Apr 26;356(17):1697-700. Epub 2007 Apr 13.
38. Owens J. 2006 drug approvals. finding the niche. Nat Rev Drug Discov. 2007Feb;6(2):99-101. Erratum in. Nat Rev Drug Discov. 2007 Mar;6(3):249.
39. Laustsen G, Gilbert M, Wimett L. Drug approvals. Nurse Pract. 2007Feb;32(2):43-51; quiz 51-2.
40. Tanne JH. FDA proposes higher fees for drug approvals to cover postmarketing surveillance. BMJ. 2007 Jan 27;334(7586):177.
41. Lexchin J. Relationship between pharmaceutical company user fees and drugapprovals in Canada and Australia. a hypothesis-generating study. AnnPharmacother. 2006 Dec;40(12):2216-22. Epub 2006 Nov 28.
42. Vedantam S. Group says FDA, advisory panels show bias toward drug approvals. Washington Post. 2006 Aug 29:A13.
43. Wynn RL. FDA new drug approvals in 2005. Gen Dent. 2006 Jul-Aug;54(4):230-3.
44. Laustsen G, Gilbert M, Wimett L. A look back at the most influential drugapprovals of 2005. Nurse Pract. 2006 Feb;31(2):26, 29-36, 41; quiz 42-3.
45. Kemp JP. Advances in the management of pediatric asthma. a review of recentFDA drug approvals and label updates. J Asthma. 2005 Oct;42(8):615-22. Review.
46. Chenoweth D. Is more really less in China's new drug approvals? Drug DiscovToday. 2005 Sep 1;10(17):1140-2.
47. Wynn RL. FDA new drug approvals in 2004. Gen Dent. 2005 Jul-Aug;53(4):246-8.
48. Hollander I. Viagra's rise above women's health issues. an analysis of thesocial and political influences on drug approvals in the United States and Japan.Soc Sci Med. 2006 Feb;62(3):683-93. Epub 2005 Jul 22.
49. Preskorn SH. Drug approvals and withdrawals over the last 60 years. JPsychiatr Pract. 2002 Jan;8(1):41-50.
50. Eggertson L. Health Canada to publish reasons for drug approvals. CMAJ. 2005 May 24;172(11):1431.
51. Carpenter DP. Defending submission-year analyses of new drug approvals.Health Aff (Millwood). 2003 Jul-Dec;Suppl Web Exclusives:W4-S3-W4-S5.
52. Lichtenberg FR. The effect of new drug approvals on HIV mortality in the US, 1987-1998. Econ Hum Biol. 2003 Jun;1(2):259-66.
53. Wynn RL. FDA new drug approvals in 2003. Gen Dent. 2004 Jul-Aug;52(4):294-8, 300.
54. Sipp D. 'Fast-track' drug approvals hit speed bumps in Japan. Nat Med. 2004Sep;10(9):883.
55. Roberts TG Jr, Chabner BA. Beyond fast track for drug approvals. N Engl JMed. 2004 Jul 29;351(5):501-5.
56. Nelson R. USA announces plan to expedite AIDS drug approvals. Lancet. 2004May 29;363(9423):1779.
57. Wynn RL. New drug approvals in 2002. Gen Dent. 2003 May-Jun;51(3):212-6.
58. Burton B. Australia makes concessions on drug approvals after US pressure.BMJ. 2004 Feb 21;328(7437):425.
59. Marwick C. Can disease-free survival be a surrogate for overall survival for drug approvals? J Natl Cancer Inst. 2004 Feb 4;96(3):173.
60. Wynn RL. New drug approvals in 2001. Gen Dent. 2002 Jul-Aug;50(4):304-8, 310.
61. Frantz S, Smith A. New drug approvals for 2002. Nat Rev Drug Discov. 2003Feb;2(2):95-6.
62. Wynn RL. New drug approvals in 2000. Gen Dent. 2001 Jul-Aug;49(4):341-5.
63. Kondro W. Drug approvals taking too long? CMAJ. 2002 Mar 19;166(6):790.
64. Davidson S. Quicker drug approvals on the way for Europe. Nat Biotechnol.2001 Sep;19(9):798-9.
65. Wynn RL. New drug approvals in 1999. Gen Dent. 2000 Jul-Aug;48(4):380-4.
66. Jacobsen K. "Fast tracking" drug approvals. is consumer safety beingcompromised? QRC Advis. 2000 Jun;16(8):5-9.
67. Wynn RL. New drug approvals in 1998. Gen Dent. 1999 May-Jun;47(3):238-40,242, 244 passim.
68. Kupecz D. Keeping up with current drug approvals. Nurse Pract. 1999Feb;24(2):44-8, 54, 56-7; quiz 58-9. Review.
69. Greenlees KJ, Bell TA. Aquaculture crop grouping and new animal drugapprovals. a CVM perspective. Vet Hum Toxicol. 1998;40 Suppl 2:19-23.
70. Rheinstein PH, Tsai VW. Keeping abreast of new drug approvals and labelingchanges. Am Fam Physician. 1998 Sep 15;58(4):995-8.
71. Piascik P. Recent biotechnology drug approvals. J Am Pharm Assoc (Wash). 1998Jul-Aug;38(4):502-5.
72. Wynn RL. New drug approvals in 1997. Gen Dent. 1998 May-Jun;46(3):230-2, 234,236.
73. Wynn RL. New drug approvals in 1996. Gen Dent. 1997 May-Jun;45(3):224-7.
74. FDA posts record number of drug approvals in 1996. Am J Health Syst Pharm.1997 Mar 1;54(5):494, 497-8.
75. Kaitin KI, Manocchia M. The new drug approvals of 1993, 1994, and 1995:trends in drug development. Am J Ther. 1997 Jan;4(1):46-54.
76. FDA drug approvals. no worse is simply not good enough. Nat Biotechnol. 1996 Apr;14(4):403.
77. Wynn RL. FDA drug approvals from 1994 to 1995. Gen Dent. 1996Mar-Apr;44(2):114, 116, 118.
78. Gatty B. FDA says 'Look at the facts' when judging its record on drugapprovals. Formulary. 1995 Jul;30(7):412, 411.
79. Ward M. User fees hold up EU agency for drug approvals. Biotechnology (N Y). 1995 Mar;13(3):213.
80. Manuel SM. 1994 biotechnology drug approvals. Am Pharm. 1995Mar;NS35(3):12-3.
81. Rawson NS. The timeliness of new drug approvals in Canada. Int J Health Serv.1995;25(1):153-65; discussion 167-71.
82. Wynn RL. FDA drug approvals in 1993-94. Gen Dent. 1995 Jan-Feb;43(1):12, 14.
83. 1993 new drug approvals. Hosp Formul. 1994 Feb;29(2):152-4.
84. Kaitin KI, Manocchia M, Seibring M, Lasagna L. The new drug approvals of1990, 1991, and 1992. trends in drug development. J Clin Pharmacol. 1994Feb;34(2):120-7.
85. Gatty B. Whatever happened to user fees and the FDA's promise to expedite newdrug approvals? Hosp Formul. 1993 Jul;28(7):656, 655.
86. Wynn RL. 1992 FDA drug approvals. Gen Dent. 1993 Jul-Aug;41(4):286-7.
87. Brown SA. The contribution of clinical pharmacology to new drug approvals. J Am Vet Med Assoc. 1993 May 15;202(10):1700-2;discussion 1713-7.
88. Miller HI. Drug approvals. Nature. 1992 Mar 19;356(6366):189.
89. Kaitin KI, DiCerbo PA, Lasagna L. The new drug approvals of 1987, 1988, and1989. trends in drug development. J Clin Pharmacol. 1991 Feb;31(2):116-22.
90. Hassall TH, Fredd SB. A physician's guide to information available from theFDA about new drug approvals. The ACG Committee on FDA-related matters. American College of Gastroenterology. Am J Gastroenterol. 1989 Oct;84(10):1222-6.
91. Beary JF 3rd. New drug approvals in 1988. South Med J. 1989 Aug;82(8):995-8.
92. Kaitin KI, Richard BW, Lasagna L. Trends in drug development. the 1985-86 newdrug approvals. J Clin Pharmacol. 1987 Aug;27(8):542-8.
93. New regulations to speed drug approvals, improve safety monitoring. FDA Drug Bull. 1985 Apr;15(1):2-3.
94. Manasse HR Jr, Stewart JE, Johnson KW. Certificate of need and statement ofsocial impact as requirements for new drug approvals. J Am Pharm Assoc. 1977Sep;17(9):567-71.