108 related articles for article (PubMed ID: 8836318)
1. ICH3: a report and background.
D'Arcy PF
Adverse Drug React Toxicol Rev; 1996 Jun; 15(2):125-7. PubMed ID: 8836318
[No Abstract] [Full Text] [Related]
2. ICH4: a report and background.
D'Arcy PF
Adverse Drug React Toxicol Rev; 1997 Aug; 16(3):199-206. PubMed ID: 9512764
[No Abstract] [Full Text] [Related]
3. The safe harbor provision of the Hatch-Waxman Act: present scope, new possibilities, and international considerations.
Coggio BD; Cerrito FD
Food Drug Law J; 2002; 57(2):161-76. PubMed ID: 12436981
[No Abstract] [Full Text] [Related]
4. [Contact and dialogue between drug companies and the global regulatory authorities throughout research and development phase].
Kock M; Thomsen MK
Ugeskr Laeger; 2003 Apr; 165(16):1649-52. PubMed ID: 12756820
[TBL] [Abstract][Full Text] [Related]
5. International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2009 Apr; 74(66):15990-1. PubMed ID: 19507321
[TBL] [Abstract][Full Text] [Related]
6. U.S.-Sino safety pact called 'modest start'. Experts say more must be done to ensure safe drug, medical device imports.
Rhea S
Mod Healthc; 2007 Dec; 37(50):12-3. PubMed ID: 18200957
[No Abstract] [Full Text] [Related]
7. International Conference on Harmonisation; guidance on Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2004 Feb; 69(24):5551-2. PubMed ID: 14968802
[TBL] [Abstract][Full Text] [Related]
8. Remarks by the Commissioner of Food and Drugs.
Kessler DA
Food Drug Law J; 1996; 51(2):207-15. PubMed ID: 11817358
[No Abstract] [Full Text] [Related]
9. An overview of international cooperation.
Holston SS
Food Drug Law J; 1997; 52(2):197-201. PubMed ID: 10557560
[No Abstract] [Full Text] [Related]
10. [Marketing of pediatric drugs].
Pabst JY
Soins Pediatr Pueric; 2003; (210):18-9. PubMed ID: 12683130
[No Abstract] [Full Text] [Related]
11. [New drugs and European procedures of approval. The European Agency for the Evaluation of Medicinal Products' role].
Ainsworth MA
Ugeskr Laeger; 2003 Apr; 165(16):1648-9. PubMed ID: 12756819
[TBL] [Abstract][Full Text] [Related]
12. The role of the pharmaceutical industry in disseminating pharmacovigilance practice in developing countries.
Shani S; Yahalom Z
Food Drug Law J; 2008; 63(3):701-11. PubMed ID: 19031669
[No Abstract] [Full Text] [Related]
13. Standards update.
Moore R
Med Device Technol; 2003; 14(1):36. PubMed ID: 12974124
[No Abstract] [Full Text] [Related]
14. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); final guidance for industry on "studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing" (VICH GL23); availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2002 Jan; 67(3):602-3. PubMed ID: 12358039
[TBL] [Abstract][Full Text] [Related]
15. International Cooperation on Harmonisation of Technical requirements for Approval of Veterinary Medicinal Products (VICH); final guidance on " Safety studies for veterinary drug residues in human food: reproduction toxicity testing" (VICH GL22); availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2002 Jan; 67(3):603-5. PubMed ID: 12365425
[TBL] [Abstract][Full Text] [Related]
16. [Does collaboration inside the European Union improve Finnish drug safety?].
Palva E
Duodecim; 2000; 116(24):2810-1. PubMed ID: 12077885
[No Abstract] [Full Text] [Related]
17. The use of standards is the name of the game.
White PB
Food Drug Law J; 1996; 51(2):337-8. PubMed ID: 11822327
[No Abstract] [Full Text] [Related]
18. International Conference on Harmonisation; guidance on Q8(R1) Pharmaceutical Development; addition of annex; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2009 Jun; 74(109):27325-6. PubMed ID: 19588572
[TBL] [Abstract][Full Text] [Related]
19. International Conference on Harmonisation; guidance on Q9 Quality Risk Management; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2006 Jun; 71(106):32105-6. PubMed ID: 16795933
[TBL] [Abstract][Full Text] [Related]
20. FDA implementation of standards developed by the International Conference on Harmonisation.
Booth PM
Food Drug Law J; 1997; 52(2):203-23. PubMed ID: 10557561
[No Abstract] [Full Text] [Related]
[Next] [New Search]
