These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
159 related articles for article (PubMed ID: 1471638)
1. Obtaining drugs from foreign markets. Shirk MB; Hale KN Am J Hosp Pharm; 1992 Nov; 49(11):2731-9. PubMed ID: 1471638 [TBL] [Abstract][Full Text] [Related]
2. Procedures for emergency or treatment use of investigational drugs. Klecker RJ; Cipolle RJ Am J Hosp Pharm; 1987 May; 44(5):1086-9. PubMed ID: 3605118 [TBL] [Abstract][Full Text] [Related]
3. Import for export; reporting and recordkeeping requirements for unapproved or violative products imported for further processing or incorporation and subsequent export--FDA. Proposed rule. Fed Regist; 1998 Nov; 63(226):64930-7. PubMed ID: 10338872 [TBL] [Abstract][Full Text] [Related]
4. Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice. Fed Regist; 1998 Jun; 63(113):32219-34. PubMed ID: 10180275 [TBL] [Abstract][Full Text] [Related]
5. 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]
6. 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]
7. TransMolecular receives FDA approval for 131-I-TM-601 IND application. Expert Rev Anticancer Ther; 2002 Apr; 2(2):139. PubMed ID: 12113233 [No Abstract] [Full Text] [Related]
8. FDA reform signed into law. Food and Drug Administration. James JS AIDS Treat News; 1997 Dec; (No 284):6-7. PubMed ID: 11364915 [TBL] [Abstract][Full Text] [Related]
9. 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]
10. Investigational new drug applications; clinical holds--FDA. Direct final rule. Fed Regist; 1998 Dec; 63(239):68676-8. PubMed ID: 10187558 [TBL] [Abstract][Full Text] [Related]
11. Preparing for an FDA preapproval inspection. Blackmer RA Qual Assur; 1994 Dec; 3(4):389-403. PubMed ID: 7613749 [TBL] [Abstract][Full Text] [Related]
12. 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]
13. A study in futility: Abigail Alliance for Better Access to Developmental Drugs will not expand access to experimental drugs for the terminally ill. Ochs A Seton Hall Law Rev; 2009; 39(2):559-603. PubMed ID: 19462540 [No Abstract] [Full Text] [Related]
14. Balancing US patent and FDA approval processes: strategically optimizing market exclusivity. Fernandez DS; Huie JT Drug Discov Today; 2004 Jun; 9(12):509-12. PubMed ID: 15183155 [No Abstract] [Full Text] [Related]
15. Investigational new drug application; exception from informed consent; technical amendment--FDA. Final rule. Fed Regist; 1997 Jun; 62(115):32479. PubMed ID: 10169828 [TBL] [Abstract][Full Text] [Related]
16. [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]
17. The FDA's drug review process: ensuring drugs are safe and effective. Meadows M FDA Consum; 2002; 36(4):19-24. PubMed ID: 12184298 [No Abstract] [Full Text] [Related]
18. FDA, off-label use, and informed consent: debunking myths and misconceptions. Beck JM; Azari ED Food Drug Law J; 1998; 53(1):71-104. PubMed ID: 11795338 [No Abstract] [Full Text] [Related]
19. 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]
20. 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] [Next] [New Search]