Timeliness of review and approval of new drugs in Canada from 1999 through 2001: is progress being made?
Rawson N. Timeliness of review and approval of new drugs in Canada from 1999 through 2001: is progress being made?. Clinical Therapeutics 25 (2003) 1230-1247
Canada's Research-Based Pharmaceutical Companies. Drug approval times in Canada. http://www.canadapharma.org/Industry_Publications/Fact_Sheets/drugapprovaltimes_01_e.pdf; 2001 [accessed March 27, 2005].
3
33749510900
Fraser Institute, Vancouver
Graham J.R. Prescription drug prices in Canada and the United States-Part 4: Canadian prescriptions for American patients are not the solution (September 2003), Fraser Institute, Vancouver
Drugs in 2001: a number of ruses unveiled. Prescrire International 2002;11:58-60.
7
33749510120
Therapeutic Products Directorate: TPD-Web. Special access programme-drugs; 2002. http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/sap_factsheet2002_e.html [accessed February 18, 2005].
8
33749524674
Who we are. The Medical Letter. http://www.medletter.com/html/who.htm; 2005 [accessed December 21, 2005].
9
33749513809
Therapeutic Products Directorate: TPD-Web. Notice of compliance listings. http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_drugs_noc_e.html - 2004; 2005 [accessed March 15, 2005].
10
33749514318
Patented Medicine Prices Review Board. Legislation, regulations and guidelines: compendium of guidelines, policies and procedures; 2004. http://www.pmprb-cepmb.gc.ca/english/View.asp?x=135&mp=73 [accessed March 27, 2005].
11
33749537891
Center for Drug Evaluation and Research. Manual of policies and procedures (MaPPs). Food and Drug Administration. http://www.fda.gov/cder/regulatory/default.htm; 2005 [accessed March 27, 2005].
12
33749512827
Food and Drug Administration. FY 2003 performance report to the president and the congress. Appendix B: list of approved applications. http://www.fda.gov/oc/pdufa/report2003/appendixb2003.html; 2005 [accessed February 18, 2005].
13
33749531587
Center for Drug Evaluation and Research. Drugs @ FDA. Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?CFID=5590034&CFTOKEN=16354048; 2005 [accessed March 27, 2005].
14
33749515485
Stat View 5.0.1. Cary, NC: SAS Institute Inc.; 1999.
15
0017360990
The measurement of observer agreement for categorical data
Landis J.R., and Koch G.G. The measurement of observer agreement for categorical data. Biometrics 33 (1977) 159-174
Center for Drug Evaluation and Research. NDAs approved in calendar years 1990-2003 by therapeutic potentials and chemical types; 2004. http://www.fda.gov/cder/rdmt/pstable.htm [accessed February 14, 2005].
17
0026676930
The clinical value of FDA class C drugs approved from 1981 to 1988
Yasuda S.U., and Woosley R.L. The clinical value of FDA class C drugs approved from 1981 to 1988. Clinical Pharmacology and Therapeutics 52 (1992) 577-582
Ursodeoxycholic acid. Primary biliary cirrhosis: dashed hopes. Prescrire International 2002;11:67-9.
19
33749506458
A quick trip to the market: ten simple steps to hasten approval times for new drugs in Canada
Tomalin A. A quick trip to the market: ten simple steps to hasten approval times for new drugs in Canada. Canadian Pharmaceutical Marketing winter (2000) 27-29