From the FDA: What's in a label? A guide for the anesthesia practitioner

Anesthesiology

Volumn 103, Issue 1, 2005, Pages 179-185

  Chang, Nancy S ^b   Simone, Arthur F ^a   Schultheis, Lex W ^b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

BUPIVACAINE; DEXMEDETOMIDINE; FENTANYL; FENTANYL CITRATE; KETAMINE; LEVOBUPIVACAINE; LORAZEPAM; MIDAZOLAM; PROPOFOL; ROPIVACAINE; SUFENTANIL CITRATE; SULFANILAMIDE; THALIDOMIDE;

ANESTHESIA; CLINICAL TRIAL; CONGENITAL MALFORMATION; DRUG CONTRAINDICATION; DRUG FORMULATION; DRUG INDICATION; DRUG LABELING; DRUG MANUFACTURE; DRUG MARKETING; DRUG METABOLISM; DRUG RESEARCH; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL PRACTICE; NONHUMAN; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; TOXICITY TESTING;

EID: 21744433546     PISSN: 00033022     EISSN: None     Source Type: Journal    
DOI: 10.1097/00000542-200507000-00026     Document Type: Review

References (17)

1. Department of Health and Human Services, Food and Drug Administration: Title 21 Code of Federal Regulations, April 1, 2003 edition. 2003. Part201, section 201.56. pp 20-1
2. Department of Health and Human Services, Food and Drug Administration: Proposed Rule: Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels. Federal Register Vol. 65, No. 247. December 22, 2000
3. Center for Drug Evaluation and Research, Food and Drug Administration: Guideline for the Study and Evaluation of Gender Differences in Clinical Evaluation of Drugs. Rockville, Maryland. Food and Drug Administration, 1993
4. Pediatric Research Equity Act of 2003. Federal Food Drug and Cosmetic Act. United States Code Title 21, Chapter 9, Subchapter V. part A. 2003
5. Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Food and Drug Administration: Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing and Labeling. Rockville, Maryland, Food and Drug Administration, 1998
6. International Conference on Harmonization: E7 Guideline for Industry: Studies in Support of Special Populations: Geriatrics. Rockville, Maryland, Food and Drug Administration, 1993
7. Center for Drug Evaluation and Research, Food and Drug Administration: Guidance for Industry: Guideline for the Study of Drugs Likely to be Used in the Elderly. Rockville, Maryland, Food and Drug Administration, 1989
8. Department of Health and Human Services, Food and Drug Administration: Title 21 Code of Federal Regulations, April 1, 2003 edition. 2003. Part 201, section 201.57(f), PP 23-9
9. Beck JM, Azari ED: FDA, off-label use, and informed consent: Debunking myths and misconceptions. Food Drug Law J 1998; 53:71-104
10. Woosley RL: Drug labeling revisions: Guaranteed to fail? JAMA 2000; 284:3047-9
11. Campbell WH, Califf, RM: Improving communication of drug risks to prevent patient injury: Proceedings of a workshop. Pharmacoepidemiol Drug Saf 2003; 12:183-94
12. Smalley W, Shatin D, Wysowski DK, Gurwitz J, Andrade SE, Goodman M, Chan KA, Platt R, Schech SD, Ray WA: Contraindicated use of cisapride: Impact of Food and Drug Administration regulatory action. JAMA 2000; 284:3036-9
13. Uhl K, Honig P: Risk management of marketed drugs: FDA and the interface with the practice of medicine. Pharmacoepidemiol Drug Saf 2001; 10:205-8
14. Department of Health and Human Services, Food and Drug Administration: Title 21 Code of Federal Regulations, April 1, 2003 edition. 2003. Part 314, section 314.94(a)(9)(iii), pp 122-3, and section 314.127(a)(8)(ii)(B), pp 144-5
15. Taniguchi T, Yamamoto K, Kobayashi T: Precipitate formed by thiopentone and vecuronium causes pulmonary embolism. Can J Anaesth 1998; 45: 347-51
16. Center for Devices and Radiological Health, Food and Drug Administration: Safety Assessment of Di(2-ethylhexl)phthalate (DEHP) Released from PVC Medical Devices. Rockville, Maryland. Food and Drug Administration, 2001
17. Department of Health and Human Services: Food and Drug Administration Drug Bulletin 1982; 12:4-5