Abstract
The product label, or package insert, is the ‘manual’ for the safe and effective use of a drug. Important pharmacokinetic and pharmacodynamic properties of a drug product should appear in the label under specific sections, as required in the Code of Federal Regulations (CFR), using a format and language recommended by the Food and Drug Administration (FDA) in various guidances to the industry. The relevant regulations and guidance documents impacting on how this information is conveyed to the healthcare professional are discussed, with special emphasis on how the new proposed rule will impact upon how information is to be conveyed. With the availability of new clinical pharmacology information not available at the time of approval, package inserts for older drugs should be updated to reflect the new data and recommend the proper dosage regimen, enabling prescribers to optimise drug therapy and minimise possible adverse events.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Peck CC, Barr WH, Benet LZ, et al. Opportunities for integration of pharmacokinetics, pharmacodynamics and toxicokinetics in rational drug development. Clin Pharmacol Ther 1992 Apr; 51(4): 465–73
General requirements on content and format of labeling for human prescription drugs, Code of Federal Regulations, 21 Part 201.56. Revised as of 1 April 2000. Washington, DC: US Government Printing Office, 2000
Specific requirements on content and format of labeling for human prescription drugs, Code of Federal Regulations, 21 Part 201.57. Revised as of 1 April 2000. Washington, DC: US Government Printing Office, 2000
FDA Guidance for Industry. Providing clinical evidence of effectiveness for human drug and biological drugs. Rockville (MD): US Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1998 May
FDA Draft Guidance for Industry. General considerations for pediatric pharmacokinetic studies for drugs and biological products. Rockville (MD): US Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1998 Nov
Specific requirements on content and format of labeling for human prescription drugs, Code of Federal Regulations, 21 Part 201.57 (f)(10). Revised as of 1 April 2000. Washington, DC: US Government Printing Office
Viagra® (sildenafil citrate) [package insert]. Groton (CT): Pfizer, 2001
FDA guidance for industry. Pharmacokinetics in patients with renal function — study design, data analysis, and impact on dosing and labeling. Rockville (MD): US Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1998 May
Draft FDA guidance for industry. Pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling. Rockville (MD): US Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1999 Nov
FDA guidance for industry. Drug metabolism/drug interaction studies in the drug development process: studies in vitro. Rockville (MD): US Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1997 Apr
FDA guidance for industry. In vivo drug metabolism/drug interaction studies-study design, data analysis, and recommendations for dosing and labeling. Rockville (MD): US Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1999 Nov
Yuan R, Parmelee T, Balian J, et al. In vitro metabolic interaction studies: experience of the Food and Drug Administration. Clin Pharmacol Ther 1999; 66: 9–15
FDA guidance for industry. Population pharmacokinetics. Rockville (MD): US Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1999 Feb
Draft FDA guidance for industry. Food effect bioavailability and bioequivalence studies. Rockville (MD): US Department of Health and Human Services, Public Health Service, Food and Drug Administration, 1997 Oct
Requirements on content and format of labeling for human prescription drugs and biologics, requirements for prescription drug products labels, proposed rule. Fed Regist, 2000 Dec 22; 65: 247
National Biosystems Inc. Focus Group Report. Physician’s perceptions of prescription drug labeling information. Contract No. 223-91-3501, 1992 Feb
Spyker D, Harvey E, Harvey B, et al. Assessment and reporting of clinical pharmacology information in drug labeling. Clin Pharmacol Ther 2000 Mar; 67(3): 196–200
Avapro® (irbesartan) [package insert]. Princeton (NJ): Bristol Myers Squibb, 2001
Toprol XL® (metoprolol succinate extended-release tablets) [package insert]. Westborough (MA): AstraZeneca, 2001
Acknowledgements
The views expressed in the article are those of the authors and not necessarily the FDA. No official endorsement by the FDA is intended or should be inferred. The authors wish to acknowledge the help and advice given by both Dr Angelica Dorantes and Dr Paul Hepp from the Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Marroum, P.J., Gobburu, J. The Product Label. Clin Pharmacokinet 41, 161–169 (2002). https://doi.org/10.2165/00003088-200241030-00001
Published:
Issue Date:
DOI: https://doi.org/10.2165/00003088-200241030-00001