FDA implements new labeling for medications used during pregnancy and lactation

American Family Physician

Volumn 94, Issue 1, 2016, Pages 12-13

  Whyte, John ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

DRUG LABELING; DRUG MANUFACTURE; EDITORIAL; FEMALE; FEMALE INFERTILITY; FOOD AND DRUG ADMINISTRATION; HUMAN; LACTATION; MALE INFERTILITY; PREGNANCY; PREGNANT WOMAN; PRESCRIPTION; REPRODUCTIVE EFFORT; RISK FACTOR; BREAST FEEDING; LEGISLATION AND JURISPRUDENCE; UNITED STATES;

BREAST FEEDING; DRUG LABELING; FEMALE; HUMANS; LACTATION; PREGNANCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84976631147     PISSN: 0002838X     EISSN: 15320650     Source Type: Journal    
DOI: None     Document Type: Editorial

References (3)

1. U.S. Food and Drug Administration. Pregnancy and lactation labeling final rule. December 3, 2014. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm. Accessed February 15, 2016.
2. Federal Register. Content and format of labeling for human prescription drug and biological products. https://www.federalregister.gov/a/2014-28241. Accessed February 15, 2016.
3. U.S. Dept. of Health and Human Services; Center for Drug Evaluation and Research; Center for Biologic Evaluation and Research. Pregnancy, lactation, and reproductive potential: labeling for human prescription drug and biological products. December 2014. http://www.fda. gov/downloads/Drugs/Guidance Compliance Regulatory Information/Guidances/UCM425398.pdf. Accessed February 15, 2016.