325 related articles for article (PubMed ID: 10137064)
1. Investigational drug tracking: Phases I-III and NDA submissions--Part I.
Grant KL
Hosp Pharm; 1994 Sep; 29(9):830-6, 839-44, 847-52 passim. PubMed ID: 10137064
[TBL] [Abstract][Full Text] [Related]
2. Investigational drug tracking: phases I-III and NDA submissions--Part II.
Grant KL
Hosp Pharm; 1994 Oct; 29(10):900, 902-4, 906-11 passim. PubMed ID: 10137850
[TBL] [Abstract][Full Text] [Related]
3. Lessons learned from independent central review.
Ford R; Schwartz L; Dancey J; Dodd LE; Eisenhauer EA; Gwyther S; Rubinstein L; Sargent D; Shankar L; Therasse P; Verweij J
Eur J Cancer; 2009 Jan; 45(2):268-74. PubMed ID: 19101138
[TBL] [Abstract][Full Text] [Related]
4. Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2003 Jun; 68(117):36675-712. PubMed ID: 12814136
[TBL] [Abstract][Full Text] [Related]
5. Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
Ceci A; Felisi M; Catapano M; Baiardi P; Cipollina L; Ravera S; Bagnulo S; Reggio S; Rondini G
Eur J Clin Pharmacol; 2002 Nov; 58(8):495-500. PubMed ID: 12451425
[TBL] [Abstract][Full Text] [Related]
6. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2008 Jul; 73(136):40453-63. PubMed ID: 18850678
[TBL] [Abstract][Full Text] [Related]
7. Applications for Food and Drug Administration approval to market a new drug; postmarketing reports; reporting information about authorized generic drugs. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2009 Jul; 74(143):37163-8. PubMed ID: 19655468
[TBL] [Abstract][Full Text] [Related]
8. Sources of regulatory information for pharmacists.
Goldwire MA; Rumore MM
Am J Hosp Pharm; 1993 Jun; 50(6):1175-81. PubMed ID: 8517457
[TBL] [Abstract][Full Text] [Related]
9. Charging for investigational drugs under an investigational new drug application. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2009 Aug; 74(155):40871-900. PubMed ID: 19691172
[TBL] [Abstract][Full Text] [Related]
10. Applications for Food and Drug Administration approval to market a new drug; postmarketing reports; reporting information about authorized generic drugs. Direct final rule.
Food and Drug Administration, HHS
Fed Regist; 2008 Sep; 73(189):56487-91. PubMed ID: 18985960
[TBL] [Abstract][Full Text] [Related]
11. The investigative process for new drugs.
Nicklas RA
Ann Allergy; 1989 Dec; 63(6 Pt 2):598-600. PubMed ID: 2688499
[TBL] [Abstract][Full Text] [Related]
12. Expanded access to investigational drugs for treatment use. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2009 Aug; 74(155):40900-45. PubMed ID: 19691173
[TBL] [Abstract][Full Text] [Related]
13. Pediatric drug development in anesthesiology: an FDA perspective.
Schultheis LW; Mathis LL; Roca RA; Simone AF; Hertz SH; Rappaport BA
Anesth Analg; 2006 Jul; 103(1):49-51. PubMed ID: 16790624
[No Abstract] [Full Text] [Related]
14. Sanofi Pharmaceuticals, Inc., et al.; withdrawal of approval of 21 new drug applications and 62 abbreviated new drug applications--FDA. Notice.
Fed Regist; 1998 May; 63(91):26191-3. PubMed ID: 10179336
[TBL] [Abstract][Full Text] [Related]
15. Investigational new drug applications; amendment to clinical hold regulations for products intended for life-threatening diseases and conditions. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2000 Jun; 65(106):34963-71. PubMed ID: 11010726
[TBL] [Abstract][Full Text] [Related]
16. FDA Modernization Act: implications for oncology.
Morris L
Oncology (Williston Park); 1998 Nov; 12(11A):139-41. PubMed ID: 10028506
[TBL] [Abstract][Full Text] [Related]
17. How are drugs approved? Part 3. The stages of drug development.
Howland RH
J Psychosoc Nurs Ment Health Serv; 2008 Mar; 46(3):17-20. PubMed ID: 18416270
[TBL] [Abstract][Full Text] [Related]
18. Trends in risks associated with new drug development: success rates for investigational drugs.
DiMasi JA; Feldman L; Seckler A; Wilson A
Clin Pharmacol Ther; 2010 Mar; 87(3):272-7. PubMed ID: 20130567
[TBL] [Abstract][Full Text] [Related]
19. Roche submits NDA for Invirase.
J Int Assoc Physicians AIDS Care; 1995 Sep; 1(8):37-8. PubMed ID: 11362796
[TBL] [Abstract][Full Text] [Related]
20. Oncology's first Phase 0 trial.
Rowan K
J Natl Cancer Inst; 2009 Jul; 101(14):978-9. PubMed ID: 19584322
[No Abstract] [Full Text] [Related]
[Next] [New Search]