Medication use in pregnancy and the pregnancy and lactation labeling rule

Clinical Pharmacology and Therapeutics

Volumn 100, Issue 1, 2016, Pages 23-25

  Sahin, L ^a   Nallani, S C ^a   Tassinari, M S ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PHARMACOLOGY; DRUG INFORMATION; DRUG LABELING; DRUG PACKAGING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; LACTATION; PREECLAMPSIA; PREGNANCY; PRESCRIPTION; PRIORITY JOURNAL; PUERPERIUM; REVIEW; SMALL FOR DATE INFANT; BREAST FEEDING; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; LEGISLATION AND JURISPRUDENCE; STANDARDS; UNITED STATES;

BIOLOGICAL PRODUCT; PRESCRIPTION DRUG;

BIOLOGICAL PRODUCTS; BREAST FEEDING; DRUG LABELING; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; LACTATION; POSTPARTUM PERIOD; PREGNANCY; PRESCRIPTION DRUGS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84966478021     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.380     Document Type: Review

References (5)

1. Content and Format of Labeling for Human Prescription Drug and Biological Products, Requirements for Pregnancy and Lactation Labeling (79 FR 72063, December 4, 2014). (2014).
2. Labeling requirements for new and more recently approved prescription drug products. 21 CFR 201.56 (d)(1) and 21 CFR 201.57(b)(9). (2015).
3. Draft Guidance for Industry "Guidance for Industry Pharmacokinetics in Pregnancy-Study Design, Data Analysis, and Impact on Dosing and Labeling." (2004).
4. Andrew, M.A. et al. Amoxicillin pharmacokinetics in pregnant women: modeling and simulations of dosage strategies. Clin. Pharmacol. Ther. 81, 547-556 (2007).
5. Commentary on Non-Labeled Dosing of Oral Amoxicillin in Adults and Pediatrics for Post-Exposure Inhalational Anthrax. (2015).